Manual de Procesamiento de Muestras

Central Laboratory
Service Manual
Artisan Pharma, Inc.
Protocol: 2-001
Covance Project Number : 510013
Manual Created : 5 June, 2007
Indianapolis
8211 SciCor Drive
Indianapolis
IN 46214-2985 USA
Tel. (317) 271-1200 (local calls)
Fax: (317) 273-4030
Singapore
1 International Business Park, #05-12A/B
The Synergy, Singapore 609917
Tel. 65-6560-8793 Fax. 65-6565-5901
Sydney
95-99 Epping Road, Macquarie Park
NSW 2113 Australia
Tel. (02) 9855-5410 Fax. (02) 9855-5419
Covance Central Laboratory Services

2003 Covance CLS. All rights reserved.
www.covance.com
Laboratory regulatory certifications available
on Covance website
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Geneva
Rue Mose-Marcinhes 7
1217 Meyrin/Geneva-CH
Tel. +41 22-989-7000 Fax. +41 22-989-1999
Cape Town
DSP Global Clinical Trials
PathCare Business Centre, PathCare Park
Neels Bothma Street, N1 City, Goodwood 7460
Tel: +27 21 596 3730
Fax: +27 21 596 3713
TABLE OF CONTENTS
Schedule Visit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 1
Kit Information
Stabilities
Holiday Considerations/Customs Closures
Collect Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 2
Visit Test Schedule
Analytes by Groups
Specimen Collection Procedures
Coagulation Testing
Blood Smear Preparation
Draw Tube Adapter Procedures
Instructions for Completing Requisition Forms
Project Specific Requisition Forms
Pack and Ship . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 3
General Information
Courier Contact Numbers
Dangerous Goods Training Information
Packaging and Shipping of Samples
Resupply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 4
General Information - Supply/Resupply
Additional Kits/Material Reorder Form
Get Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 5
Reference Ranges/Alerts and Flags
Project Specific Reference Ranges and/or Alerts and Flags
Get Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 6
Covance CLS Customer Service Contact Numbers
Laboratory Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 7
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 8
Archived Pages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 10
Disclaimer:
The Created Version Date and the Revised Version Date on the cover of the manual refer to either the original publication of the manual
or the customer requested changes to the protocol specific pages. The dates on the Covance standard pages are not necessarily
representative of the Revised Version Date, as the updates of these pages are due to Covance internal changes or regulatory changes,
which can occur at anytime.
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KIT INFORMATION
Kits are protocol, investigator and visit specific.
Select the correct kit accordingly.
Please check kit expiration dates before

using the kit!
Some tubes used for the collection of samples
have expiration dates. These dates are defined
by tube manufacturers.
To ensure the validity of the tubes contained in
the collection kit, expiration dates are printed on
the outside of the kit box. The expiration date of
each kit corresponds to the shortest expiration
date of the tube(s) within the kit.
Please do not collect specimens in expired
containers!
Specimens received in an expired container
which includes an additive will be canceled as:
Sample drawn in expired tube: Testing not
performed.
If you have expired tubes please call Covance
CLS to have these kits replaced and your
inventory updated.
0001
A unique accession number is assigned to each

kit and its requisition form. Within the kit,
specimen containers and the requisition have the
same accession number (code bar).
Do not interchange the tubes
requisition forms between kits!
and/or
Complete the labels with appropriate identifiers

(screening number and/or patient number, etc.).
Each container label is pre-printed with an

internal Covance code, which is to be its primary
source of identification.
A-B
Y005
Bulk Supplies
A standard bag, containing the items most frequently used in clinical trials is provided in the initial supplies.
Depending on your protocol, additional items may be provided. For some studies, no bulk supply is provided.
2003 Covance CLS
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STABILITIES FOR ANALYTES IN SPECIMENS
Listed below are stabilities at ambient storage.

Covance Central Laboratory Services must receive specimens within the stability period established by our
laboratory in order to test the specimen.
If you have questions relating to analytes not listed, please call us.
Analyte
Chemistry Group
Total Bilirubin
Alkaline Phosphatase
LDH
GGT
ALT (SGPT)
AST (SGOT)
Urea Nitrogen
Creatinine
Uric Acid
Phosphorus
Calcium
Glucose
Total Protein
Albumin
CK
Hours
72
120
120
120
72
72
120
120
120
120
120
72
120
72
72
Days
3
5
5
5
3
3
5
5
5
5
5
3
5
3
3
Electrolytes
Sodium
Potassium
Bicarbonate
Chloride
Magnesium
120
120
72
120
120
5
5
3
5
5
Lipids
Triglycerides
Cholesterol
HDL Cholesterol
LDL Cholesterol
120
120
120
120
5
5
5
5
Hours
Days
Urinalysis
Color
Clarity
Specific Gravity
pH
Protein
Glucose
Ketones
Bilirubin
Urobilinogen
Blood
Nitrite
Leukocyte Esterase
Microscopic
96
96
96
96
96
96
96
96
96
96
96
96
96
4
4
4
4
4
4
4
4
4
4
4
4
4
Hematology
Hemoglobin
Hematocrit
RBC
MCV
MCH
MCHC
WBC
Neutrophils
Bands
Lymphocytes
Monocytes
Eosinophils
Basophils
Platelets
Morphology
72
60
72
60
72
60
72
72
72
72
72
72
72
72
72
3
2.5
3
2.5
3
2.5
3
3
3
3
3
3
3
3
3
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Analyte
CUSTOMS CLOSED/PUBLIC HOLIDAYS

!
Important considerations
Local courier service (pickup and delivery) may be limited prior to, during and following observed
holidays in the country you are shipping specimens to. It is imperative that you check local service
schedules in advance of the holiday. Listed below are important considerations when planning your
patient visits during the holidays.
- Your courier service reserves the right to observe earlier than usual pick-up times during the
holidays. Call your courier service for local pick-up schedules.
- During the December holidays, schedule your pickups in advance of the holiday where possible.
- Call early in the day to schedule your pickup.
- When a holiday is observed on Monday, avoid laboratory collections on the preceding Saturday (e.g.
Labor Day).
- Frozen specimens should NOT be shipped on the day before the observed holiday. Send frozen
specimens on the next available business day.
- If shipping specimens on Friday, mark airbill for Saturday delivery.
- Specimens with short stabilities (eg. lymphocyte subsets, reticulocyte counts, etc.) should not be
collected on the day prior to the holiday.
For sites with 48-hour inbound transit:

- Do not ship samples within 48 hours prior to an official holiday (see dates on next pages).
- If a holiday falls on Monday - Thursday and is not also observed in your country, you may ship
samples that same day.
Holiday reminders are also available on the Covance website:

www.covance.com/investigators/holidays.pdf
English_Custom Closed/Public Holidays 1/3_Update: 20060707
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CALENDAR
US, Canada, Puerto Rico and Latin America (specimens sent to Indianapolis)
2006
2007
2008
1 January
29 May
4 July
4 September
23 November
24 November *
25 December
1 January
28 May
4 July
3 September
22 November
23 November *
25 December
1 January
26 May
4 July
1 September
27 November
28 November *
25 December
New Year's Day

Memorial Day
Independence Day
Labor Day
Thanksgiving Day
Thanksgiving Day
Christmas Day
For sites in US and Canada

If you ship specimens on a Thursday that is a holiday in United States, you should mark Saturday
delivery on the airbills.
Please check also your local holidays, they could cause delays.
For sites with 48 hours delivery time to Indianapolis, do not schedule any shipment 24 or 48 hours
before one of these dates.
* limited operations within Covance this day due to Thanksgiving period.
Europe, Middle East and Africa (specimens sent to Geneva)

2006
2007
2008
1 January
14 April
17 April
25 May
5 June
1 August
7 September
24 December
25 December
31 December
1 January
6 April
9 April
17 May
28 May
1 August
6 September
24 December
25 December
31 December
1 January
21 March
24 March
1 May
12 May
1 August
11 September
24 December
25 December
31 December
New Year's Day

Good Friday
Easter Monday
Ascension Day
Whit Monday
Swiss National Day
Jene Genevois
Christmas Eve
Christmas Day
New Year's Eve
Please check also your local holidays, they could cause delays.
For sites with 24 hours delivery time to Geneva, do not schedule any shipment 24 hours before one of
these dates.
For sites with 48 hours delivery time to Geneva, do not schedule any shipment 48 hours before one of
these dates.
2003 Covance CLS
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CALENDAR
Asia (specimens sent to Singapore)

2006
2007
1 January
2 January
10 January
29 January
30 January
31 January
14 April
1 May
12 May
9 August
21 October
24 October
25 December
31 December
1 January
2 January
18 February
19 February
20 February
6 April
1 May
31 May
9 August
13 October
8 November
20 December
25 December
-
New Year's Day

Public Holiday
Hari Raya Haji
Chinese New Year
Chinese New Year
Chinese New Year
Public Holiday
Good Friday
Labour Day
Vesak Day
National Day
Deepavali
Hari Raya Puasa
Deepavali
Hari Raya Haji
Christmas Day
Hari Raya Haji
Taiwan Customs are closed on Saturday/Sunday.
Do not schedule patients

for the following dates:
9 January 2006
27-29 January 2006
13 April 2006
29-30 April 2006
10-11 May 2006
8 August 2006
20 October 2006
23 October 2006
23-24 December 2006
16-17 January 2007
5 April 2007
29-30 April 2007
29-30 May 2007
8 August 2007
12 October 2007
7 November 2007
23-24 December 2007
Australia, New Zealand and Asia (specimens sent to Sydney)

2006
2007
2008
1 January
2 January
26 January
14 April
15 April
17 April
25 April
12 June
2 October
25 December
26 December
1 January
26 January
6 April
7 April
9 April
25 April
11 June
1 October
25 December
26 December
1 January
26 January
21 March
22 March
24 March
25 April
9 June
6 October
25 December
26 December
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New Year's Day

Public Holiday
Australia Day
Good Friday
Easter Saturday
Easter Monday
Anzac Day
Queens Birthday
Labour Day
Christmas Day
Boxing Day
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LABORATORY VISIT SCHEDULE FOR PROTOCOL 2-0

001
VISIT Baseline
OCCURRENCE Day 0
TEST GROUPS
Hematology & Differential Panel
Hematology II
Chemistry Panel
INR
D-Dimer
Fibrinogen
Specimen Management
SMI/ART-123 Ab
SMII/ART-123 Concentration
DMI/Exploratory (Citrate)
DMII/Exploratory (EDTA)
DMIII/Thrombomodulin Level
Day 1
Day 3
Day 3
Day
Early
Day 7 Day 14
Retest
Post Dose Pre Dose Post Dose
28/EOS Termination
Day 1
Day 3
Day 3 Day 7 Day 14 Day 28
N/A
N/A
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
O
O
O
X
X
X
X
X
X
X
X
X
X
X
X
X
O
O
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
O
O
O
O
O
O
O
O
O
O
O
X Mandatory testing
O Optional testing
Kit - Early Termination

For use when a subject discontinues the study early.
Kit - Retest
This kit can be used:
- for repeat or follow-up testing
- to redo analyses at any time during the trial or
- to substitute for any kit, if you do not have the appropriate kit in stock. If so, please cross through Retest
and write the visit name on the requisition form.
Make sure that you order all tests required for the visit being performed.
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ANALYTES BY GROUPS FOR PROTOCOL 2-0

001
CHEMISTRY PANEL
Total Bilirubin
Alkaline Phosphatase
ALT (SGPT)
AST (SGOT)
LDH
Urea Nitrogen
Creatinine
Glucose
Calcium
Sodium
Potassium
Bicarbonate
Chloride
HEMATOLOGY & DIFFERENTIAL PANEL

Hemoglobin
Hematocrit
WBC
Neutrophils (%, abs)
Bands (%, abs)
Lymphocytes (%, abs)
Monocytes (%, abs)
Eosinophils (%, abs)
Basophils (%, abs)
Platelets
INR
Prothrombin Time
International Normalized Ratio
(Non-Anticoag Calculation)
DMI/ EXPLORATORY (CITRATE)

TAT
F1.2
Protein C - antigen
aPC
PAI-1-antigen
Antithrombin III
IL-6
IL-10
MPO
Procalcitonin
HS, CRP
D-DIMER
D-Dimer (enzyme immunoassay)
FIBRINOGEN
SMI/ART-123 AB
HEMATOLOGY II
Platelets
SMII/ART-123 CONCENTRATION
DMII/EXPLORATORY (EDTA)
PCI
C5a (anaphylatoxin)
DMIII/THROMBOMODULIN LEVEL
Thrombomodulin Level
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SPECIMEN COLLECTION PROCEDURES FOR PROTOCOL 2-0

001
Covance
containers
code
Vacutainer
collection
containers
Equivalent
Monovette
if applicable
Shipping
temperature
Shipping
frequency
SERUM
Chemistry Panel
One 3.5 ml gold top serum separation tube. Fill tube completely. It is important to thoroughly mix the blood with
the clotting activation agent by inverting the tube not less than five times. Allow blood to clot for 30 minutes
(tube standing upright). Centrifuge at a minimum of 1500 x g for 15 minutes until clot and serum are separated
by a well-formed polymer barrier. Use pipette provided to transfer all the serum into the 5 ml plastic vial labelled
CHEMISTRY.
Day of
collection
Ambient
Recommendations regarding the proper use of centrifuge:

Centrifuge operators should evaluate the size of collection tubes compared to the buckets that are used in
the centrifuge. Most centrifuges have different types of buckets available for purchase from the vendor.
Tubes requiring centrifugation must rest on the bottom of the bucket that is used. If a tube is short and does
not rest on the bottom of the bucket that is used, a spacer provided by the centrifuge vendor should be
inserted into the bucket. Alternatively, a different bucket which allows the tube to rest on the bottom should
be used. Warning: if the bottom of the tube does not rest on the bottom of the centrifuge bucket, the
cap may loosen or come off during centrifugation.
Equation for calculating the relative centrifugal force
Specimens requiring centrifugation must meet the following guidelines set by the NCCLS (National
Committee for Clinical Laboratory Standards). All specimens should be spun at a minimum of 1500 x g for
15 minutes unless otherwise indicated.
F: gravitional force [g]
R: radius measured from the center of rotation to the bottom of tube in the rotor [cm]
N: speed of the centrifuge rotor [rpm = rotation per minute]
Example: with a radius of 10 cm and 1500 g the required speed is:
1500
0.00001118(10)
F
0.00001118(R)
N= 3663 rpm
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N=
N=

001
Covance
containers
code
Vacutainer
collection
containers
Equivalent
Monovette
if applicable
Shipping
temperature
Shipping
frequency
SERUM
SMI/ART-123 Ab
One 3.5 ml gold top serum separation tube. Fill tube completely. It is important to thoroughly mix the blood
with the clotting activation agent by inverting the tube not less than five times. Allow blood to clot for 30 minutes
(tube standing upright). Centrifuge at a minimum of 1500 x g for 15 minutes until clot and serum are separated
by a well-formed polymer barrier. Use pipette provided to transfer all the serum into the plastic vial labelled
SMI/ART-123 AB FROZEN. FREEZE IMMEDIATELY on dry ice and ship frozen to Covance on day of
collection.
Frozen
Day of
collection
PLASMA
INR - D-Dimer - Fibrinogen
One 4.5 ml blue top sodium citrate tube. Fill tube completely. Mix immediately by gently inverting the tube at
least 8 to 10 times. Centrifuge at a minimum of 1500 x g for 15 minutes until cells and plasma are well
separated. Use pipette provided to transfer the plasma equally into the 3 ml plastic vial labelled
INR/FIBRINOGEN FROZEN and the 5 ml plastic vial labelled D-DIMER FROZEN. Freeze immediately at
20C or -70C until shipment.
Frozen
Day of
collection
One 6 ml green top sodium heparin tube. Mix immediately by inverting tube 10 to 15 times. Centrifuge
immediately at 1500 x g for 10 to 15 minutes. Use the enclosed pipette to transfer the plasma into the plastic
vial labelled SMII/ART-123 CONC FROZEN. FREEZE IMMEDIATELY on dry ice and ship frozen to Covance
on day of collection.
Frozen
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Day of
collection

001
Covance
containers
code
Vacutainer
collection
containers
Equivalent
Monovette
if applicable
Shipping
temperature
Shipping
frequency
PLASMA
DMI/Exploratory (Citrate) - DMIII/Thrombomodulin Level (if applicable)
Two (2) 4.5 ml blue top sodium citrate tubes. Fill tubes completely. Mix immediately by gently inverting the
tubes at least 8 to 10 times. Centrifuge at a minimum of 2500 x g for 15 minutes until cells and plasma are well
separated. Use pipette provided to transfer all the plasma from both tubes equally into the 8 plastic vials
labelled EXPLOR (CITRATE) FROZEN. FREEZE IMMEDIATELY on dry ice and ship frozen to Covance on day
of collection.
Frozen
Day of
collection
One (1) 4.0 ml lavendar top EDTA tube. Fill tube completely. Mix immediately by gently inverting the tube at
least 8 to 10 times. Centrifuge at a minimum of 2500 x g for 15 minutes until cells and plasma are well
separated. Use pipette provided to transfer all the plasma into the 4 plastic vials labelled EXPLOR (EDTA)
FROZEN. FREEZE IMMEDIATELY on dry ice and ship frozen to Covance on day of collection.
Frozen
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Day of
collection

001
Covance
containers
code
Vacutainer
collection
containers
Equivalent
Monovette
if applicable
Shipping
temperature
Shipping
frequency
WHOLE BLOOD
or
Hematology II
Draw whole blood samples last except when collecting coagulation group at the same visit.
One 3 ml lavender top tube. Fill tube completely. Mix immediately by gently inverting the tube at least 8 to 10
times.
Make blood smears with blood from the lavender top tube using the Diff-Safe dispenser. Make two slides.
Allow to air dry and place in blue slide mailer.
Do not forget to ship the tube after using it for the hematology slides.
Ambient
2003 Covance CLS
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Day of
collection
SPECIMEN COLLECTION PROCEDURES FOR COAGULATION TESTING
Plasma
Special care is needed for collecting and handling blood samples intended for
coagulation testing. If sample clotting or hemolysis occurs during specimen
collection or the aliquot is contaminated with platelets from the plasma cell interface
that is created by centrifugation, the test result will be invalid.
Check the expiration date on all collection tubes. If the tube has expired, obtain a fresh tube
from your site's supplies. Place an extra Covance label from the kit on the tube and write the
test name on the label.
Blood Collection Precautions
Optimal blood specimens for coagulation testing are obtained by venipuncture using a blood
collection system that collects the specimen directly into a tube containing the
anticoagulant.
Blood samples that are collected using a winged blood collection set (butterfly needle) have
a longer path between the vein and the anticoagulant and are at higher risk of clot formation
and invalid results.
Blood samples should not be collected using a syringe due to the increased risk of that the
sample may clot or hemolyze.
Use of a vascular device (VAD) is not recommended for coagulation blood sample
collections. Blood samples collected from a vascular device (VAD) are at risk of sample
dilution with flush (saline/heparin) or infusion fluids, hemolysis and a significant increased
risk of a clotted sample.
2003 Covance CLS
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SPECIMEN COLLECTION PROCEDURES FOR COAGULATION TESTING
Please make sure that all screw caps are tightly secured!
Plasma
Methods for Obtaining Blood Specimens for Coagulation Testing
Venipuncture: If multiple collection tubes are being filled, draw the citrate tube last. If the citrate is the first tube
drawn, a discard tube should be drawn first. Mix the blood with the additive thoroughly by gentle inversion 8
to10 times.
Blood Collection from a vascular access device (VAD) such as a central Line or an indwelling catheter:
withdraw and discard at least 2 mL of blood. Draw the citrate tube first, immediately mixing well the additive
and the blood by gentle inversion 8 to 10 times.
Note: tube should be completely filled by the vacuum in order to obtain the correct ratio of
blood to anticoagulant. Inadequate filling of the collection tube will decrease this ratio, and
will lead to inaccurate results.
1. Centrifuge the citrate tube within 30 minutes after draw. A centrifuge with a swing-out bucket rotor is
recommended. Do not refrigerate the blood prior to centrifugation.
2. Centrifuge the citrate tube at a minimum of 1500 g for at least 15 minutes. Centrifugation at lower speeds
for longer times is not acceptable.
3. Allow the centrifuge to stop without using the braking mechanism.
4. Immediately and carefully remove the citrate tube from the centrifuge, taking care not to knock or invert the
tube. You must not disturb the plasma/cell interface. Place the tube into a rack to allow it to stand upright.
5. Carefully remove the tube stopper and, using a fresh pipette, remove the plasma and place the plasma into
the labeled Covance transport tube.
Note: use the Covance-supplied pipette. Do not use the same pipette as used for separation
of serum. Hold the tube up to a strong light so that you can see the plasma/cell interface
clearly. You may see a hazy layer above the blood cells. This hazy layer contains platelets. Do
NOT place the pipette into this layer or touch the layer with the pipette. Do NOT aspirate any
of this layer.
6. After placing the separated plasma into the Covance transport tube, check to be sure that the transport tube
is labeled with the patient identification (initials or patient ID number).
7. Secure the screw cap lid(s).
8. Discard draw tube. Do NOT send back to Covance.
9. Immediately place the plasma into a -20C or -70C freezer. Ship the frozen plasma to Covance on dry ice
as directed in your protocol.
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BLOOD SMEAR PREPARATION
1. Write appropriate identifiers on the frosted

end of both hematology slides using a pencil.
2. After mixing the hematology tube, insert the

Diff-Safe dispenser into the rubber stopper.
3. Turn the tube upside down and press the DiffSafe dispenser against the slide, 0.5 cm from
the frosted end. Discontinue pressure the
instant the drop appears.
4. Holding the second slide at a 30 angle, pull

the slide towards the drop of blood until
contact is made.
5.
Remove the Diff-Safe dispenser and

discard it in an approved medical
waste container. Do not forget to
ship the tube with the hematology
slides!
Allow the droplet to draw completely across

the edge of the slide. Gently push the second
slide forward (only allowing the weight of the
slide to be applied on the glass surface).
2003 Covance CLS
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6. Repeat the process for the other slide. Allow

the slides to air dry thoroughly while lying flat.
Return slides to plastic mailer(s) for
shipment.
BLOOD SMEAR PREPARATION
Examples of well-made slides.
Examples of incorrect slides!
2003 Covance CLS
English_Blood Smear Preparation 2/2_Update: 20021015
Page: 19
510013_TMEA_Printed: 20070606
SINGLE USE NEEDLE PROTECTION DEVICE INSTRUCTIONS

INSTRUCTIONS FOR USE:
Holding both pink shield and

green cap, twist and remove
white cap.
While holding the needle firmly,

screw holder onto needle until
it fits securely.
(a) Rotate pink safety shield

back toward the holder.
(b) Twist and pull green needle
cap straight off.
Perform venipuncture according to your facility's established

procedures.
Immediately after removing

needle from vein, cover needle
by pushing pink safety shield
forward with thumb until an
audible click is heard. DO NOT
attempt to engage shield by
pressing against hard surface.
DO NOT remove needle from

holder. Dispose of the needle
and holder as one unit into
nearest sharps container. DO
NOT REUSE.
IMPORTANT SAFETY TIPS
DO NOT REUSE HOLDER
Holder threads are designed to be used ONLY ONCE. Reuse of

holder is potentially unsafe and could result in serious injury or
exposure to bloodborne pathogens.
Once holder has been attached to the needle, DO NOT UNWIND it

to readjust, or to change needles.
Dispose of needle and holder as a single unit.
BD, BD Logo and Eclipse are trademarks of Becton, Dickinson and Company. 2002 BD.
2003 Covance CLS
English_Venipuncture Needle Protection Device_Update: 20050310
Page: 20
510013_TMEA_Printed: 20070606
BD Vacutainer Systems
Preanalytical Solutions
1 Becton Drive
Franklin Lakes, NJ 07417
INSTRUCTIONS FOR COMPLETING REQUISITION FORMS
@
!
Please complete all the required information with a black ball point pen. This information is required
for patient identification and result reporting.
Any errors or missing details with regard to patient demographics will cause a delay in the
reporting of the results until information is verified!
Send the white copy of the completed requisition form together with the relevant samples to Covance Central
Laboratory Services
1. Patient number
1. Patient initials (if applicable)
2. Birthdate
2. Check the appropriate box
3. Specimen collection date
3. Specimen collection time
Check the appropriate box
(if applicable to your site)
GENERIC
REQUISITION
FORM
1. Information required for patient

identification.
2. Information required in order to
provide age and gender for
specific reference ranges.
3. Information required to calculate
specimen stability.
Write your comments here
2003 Covance CLS
English_Instructions for Completing Requisition Forms_Update: 20040108
Page: 21
510013_TMEA_Printed: 20070606
Covance Central Laboratory Services, Inc.

8211 SciCor Dr.
Indianapolis, IN 46214-2985
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req
THE ACCESSION NUMBER IS

THE REFERENCE NUMBER
FOR COMMUNICATION WITH
COVANCE.
VISIT: BASELINE
COMPLETE ALL BOXES IN THIS SECTION WITH BLACK BALL POINT

PEN. FAILURE TO COMPLETE ALL BOXES WILL DELAY REPORTS.
Randomization #
Page 1 of 2
2-part
Covance
internal
use
ONLY
Employee Visa
Laboratory Requisition Form

Protocol: 2-001
Investigator : Inv_n
Address_1
Address_2
Address_3
Address_4
Address_5
Address_6
Address_7
Site #
Pt #
Subject Initials
Kit #
First
Middle
Family/Last
(If no middle initial, a dash will be

used)
Birthdate
Day
Month
Sex
Male
Female
Collection Date
Day
Month
Year
Complete month field in English

(Example: 02 JUN 1968)
Year

(Example: 01 JAN 2001)
Collection Time
24 Hour Clock
(Record Midnight as 23:59)
Requisition Completed by
Full name in capital letters
Tube Count
Samples Collected by
Ambient=
Phone number
Of the person completing the
requisition
Frozen=
All DIC and coagulation tests taken for the purposes of this study must be taken from an
original stick or venipuncture. All other blood tests may be taken from an existing port or line.
To avoid clotting cancellations, a small amount of blood must be collected from the
venipuncture site before the blood is drawn into the sodium citrate blue top tube.
Refrig=
Slides=
Specimen to be collected immediately before the first dose of the study.

Was the DIC/Coagulation testing collected from
an original stick/venipuncture?
Validation
YES
NO
(Check one box - mandatory)
REQUIRED TESTING refer to page 2 for collection and shipping instructions
First Entry
Second Entry
ADDITIONAL TESTING IS NOT ALLOWED

Bar_req
Comments:
WHITE COPY-COVANCE
PINK COPY-INVESTIGATOR
PLEASE DO NOT RETURN EMPTY CONTAINERS TO COVANCE.
Covance internal use ONLY
Bar_req
Label_6
510013
Af 070605
Page: 22
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
Page 2 of 2
2-part
THE FOLLOWING REQUIRED SPECIMENS MUST BE SHIPPED AMBIENT DAY OF COLLECTION:
Chemistry Panel
One 3.5 ml gold top serum separation tube. Fill tube completely. It is important to thoroughly mix the blood with the clotting
activation agent by inverting the tube not less than five times. Allow blood to clot for 30 minutes (tube standing upright).
Centrifuge at a minimum of 1500 x g for 15 minutes until clot and serum are separated by a well-formed polymer barrier. Use
pipette provided to transfer all the serum into the 5 ml plastic vial labelled CHEMISTRY.
One 3 ml lavender top tube. Fill tube completely. Mix immediately by gently inverting the tube at least 8 to 10 times.
Make blood smears with blood from the lavender top tube using the Diff-Safe dispenser. Make two slides. Allow to air dry and
place in blue slide mailer.
THE FOLLOWING REQUIRED SPECIMENS MUST BE SHIPPED FROZEN ON DRY ICE DAY OF COLLECTION:
One 4.5 ml blue top sodium citrate tube. Fill tube completely. Mix immediately by gently inverting the tube at least 8 to 10 times.
Centrifuge at a minimum of 1500 x g for 15 minutes until cells and plasma are well separated. Use pipette provided to transfer the
plasma equally into the 3 ml plastic vial labelled INR/FIBRINOGEN FROZEN and the 5 ml plastic vial labelled D-DIMER
FROZEN. Freeze immediately at 20C or -70C until shipment.
SMI/ART-123 Ab
pipette provided to transfer all the serum into the plastic vial labelled SMI/ART-123 AB FROZEN. FREEZE IMMEDIATELY on
dry ice and ship frozen to Covance on day of collection.
DMI/Exploratory (Citrate) - DMIII/Thrombomodulin Level
Two (2) 4.5 ml blue top sodium citrate tubes. Fill tubes completely. Mix immediately by gently inverting the tubes at least 8 to 10
times. Centrifuge at a minimum of 2500 x g for 15 minutes until cells and plasma are well separated. Use pipette provided to
transfer all the plasma from both tubes equally into the 8 plastic vials labelled EXPLOR (CITRATE) FROZEN. FREEZE
IMMEDIATELY on dry ice and ship frozen to Covance on day of collection.
One (1) 4.0 ml lavendar top EDTA tube. Fill tube completely. Mix immediately by gently inverting the tube at least 8 to 10 times.
Centrifuge at a minimum of 2500 x g for 15 minutes until cells and plasma are well separated. Use pipette provided to transfer all
the plasma into the 4 plastic vials labelled EXPLOR (EDTA) FROZEN. FREEZE IMMEDIATELY on dry ice and ship frozen to
Covance on day of collection.
WHITE COPY-COVANCE
Bar_req
Label_6
1 510013
Af 070605
Page: 23
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
VISIT: DAY 1 POST DOSE

Randomization #
Page 1 of 2
2-part
Covance
internal
use
ONLY
Employee Visa

Protocol: 2-001
Address_1
Address_2
Address_3
Address_4
Address_5
Address_6
Address_7
Site #
Pt #
Subject Initials
Kit #
First
Middle
Family/Last

used)
Birthdate
Day
Month
Sex
Male
Female
Collection Date
Day
Month
Year

(Example: 02 JUN 1968)
Year

Collection Time
24 Hour Clock
Tube Count
Ambient=
Phone number
requisition
Frozen=
Refrig=
Slides=
Specimens to be collected 12 hours (plus or minus 1 hour) after the first dose of study drug.
Validation
YES
NO
First Entry
Second Entry

Bar_req
Comments:
WHITE COPY-COVANCE
Bar_req
Label_6
510013
Af 070605
Page: 24
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
Page 2 of 2
2-part
Hematology II
One 6 ml green top sodium heparin tube. Mix immediately by inverting tube 10 to 15 times. Centrifuge immediately at 1500 x g
for 10 to 15 minutes. Use the enclosed pipette to transfer the plasma into the plastic vial labelled SMII/ART-123 CONC
WHITE COPY-COVANCE
Bar_req
Label_6
2 510013
Af 070605
Page: 25
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
VISIT: DAY 3 PRE DOSE

Randomization #
Page 1 of 2
2-part
Covance
internal
use
ONLY
Employee Visa

Protocol: 2-001
Address_1
Address_2
Address_3
Address_4
Address_5
Address_6
Address_7
Site #
Pt #
Subject Initials
Kit #
First
Middle
Family/Last

used)
Collection Date
Day
Month
Year

Collection Time
24 Hour Clock
Phone number
Tube Count

requisition
Ambient=
Frozen=
Refrig=
Specimens to be collected immediately before the 3rd dose of study drug.

Slides=
YES
NO
Validation
First Entry
Second Entry

Bar_req
Comments:
WHITE COPY-COVANCE
Bar_req
Label_6
510013
Af 070605
Page: 26
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
Page 2 of 2
2-part
Chemistry Panel
WHITE COPY-COVANCE
Bar_req
Label_6
3 510013
Af 070605
Page: 27
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
VISIT: DAY 3 POST DOSE

Randomization #
Page 1 of 2
2-part
Covance
internal
use
ONLY
Employee Visa

Protocol: 2-001
Address_1
Address_2
Address_3
Address_4
Address_5
Address_6
Address_7
Site #
Pt #
Subject Initials
Kit #
First
Middle
Family/Last

used)
Collection Date
Day
Month
Year

Collection Time
24 Hour Clock
Phone number
Tube Count

requisition
Ambient=
Frozen=
Refrig=
Specimens to be collected 12 hours (plus or minus 1 hour) after the third dose of study drug.

Slides=
YES
NO
Validation
First Entry
Second Entry

Bar_req
Comments:
WHITE COPY-COVANCE
Bar_req
Label_6
510013
Af 070605
Page: 28
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
Page 2 of 2
2-part
Hematology II
WHITE COPY-COVANCE
Bar_req
Label_6
4 510013
Af 070605
Page: 29
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
VISIT: DAY 7

Randomization #
Page 1 of 2
2-part
Covance
internal
use
ONLY
Employee Visa

Protocol: 2-001
Address_1
Address_2
Address_3
Address_4
Address_5
Address_6
Address_7
Site #
Pt #
Subject Initials
Kit #
First
Middle
Family/Last

used)
Collection Date
Day
Month
Year

Collection Time
24 Hour Clock
Phone number
Tube Count

requisition
Ambient=
Frozen=
Refrig=
Specimens to be collected 144 hours (plus or minus 2 hrs) after the first dose of study drug.
Slides=
YES
NO
Validation
First Entry
Second Entry

Bar_req
Comments:
WHITE COPY-COVANCE
Bar_req
Label_6
510013
Af 070605
Page: 30
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
Page 2 of 2
2-part
Chemistry Panel
SMI/ART-123 Ab
WHITE COPY-COVANCE
Bar_req
Label_6
5 510013
Af 070605
Page: 31
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
VISIT: DAY 14

Randomization #
Page 1 of 2
2-part
Covance
internal
use
ONLY
Employee Visa

Protocol: 2-001
Address_1
Address_2
Address_3
Address_4
Address_5
Address_6
Address_7
Site #
Pt #
Subject Initials
Kit #
First
Middle
Family/Last

used)
Collection Date
Day
Month
Year

Collection Time
24 Hour Clock
Phone number
Tube Count

requisition
Ambient=
Frozen=
Refrig=

YES
NO
Slides=

Validation
First Entry
Second Entry

Bar_req
Comments:
WHITE COPY-COVANCE
Bar_req
Label_6
510013
Af 070605
Page: 32
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
Page 2 of 2
2-part
Chemistry Panel
SMI/ART-123 Ab
WHITE COPY-COVANCE
Bar_req
Label_6
6 510013
Af 070605
Page: 33
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
VISIT: DAY 28/EOS

Randomization #
Page 1 of 1
2-part
Covance
internal
use
ONLY
Employee Visa

Protocol: 2-001
Address_1
Address_2
Address_3
Address_4
Address_5
Address_6
Address_7
Site #
Pt #
Subject Initials
Kit #
First
Middle
Family/Last

used)
Collection Date
Day
Month
Year

Collection Time
24 Hour Clock
Phone number
Tube Count

requisition
Ambient=
REQUIRED TESTING refer to collection and shipping instructions below

Frozen=

Chemistry Panel
the clotting activation agent by inverting the tube not less than five times. Allow blood to clot for 30 minutes (tube
standing upright). Centrifuge at a minimum of 1500 x g for 15 minutes until clot and serum are separated by a
well-formed polymer barrier. Use pipette provided to transfer all the serum into the 5 ml plastic vial labelled
CHEMISTRY.
Refrig=
Slides=

One 3 ml lavender top tube. Fill tube completely. Mix immediately by gently inverting the tube at least 8 to 10
times.
Make blood smears with blood from the lavender top tube using the Diff-Safe dispenser. Make two slides. Allow
to air dry and place in blue slide mailer.
Validation
First Entry
Second Entry
THE FOLLOWING REQUIRED SPECIMENS MUST BE SHIPPED FROZEN ON DRY ICE DAY OF
COLLECTION:
SMI/ART-123 Ab
the clotting activation agent by inverting the tube not less than five times. Allow blood to clot for 30 minutes (tube
standing upright). Centrifuge at a minimum of 1500 x g for 15 minutes until clot and serum are separated by a
well-formed polymer barrier. Use pipette provided to transfer all the serum into the plastic vial labelled SMI/ART123 AB FROZEN. FREEZE IMMEDIATELY on dry ice and ship frozen to Covance on day of collection.

Bar_req
Comments:
WHITE COPY-COVANCE
Bar_req
Label_6
510013
Af 070605
Page: 34
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
VISIT: EARLY TERMINATION

Randomization #
Page 1 of 2
2-part
Covance
internal
use
ONLY
Employee Visa

Protocol: 2-001
Site #
Pt #
Kit #
PVC =
Day #
Address_1
Address_2
Address_3
Address_4
Address_5
Address_6
Address_7
Subject Initials
First
Middle
Family/Last

used)
Collection Date
Day
Month
Year

Collection Time
24 Hour Clock
Tube Count
Ambient=
Phone number
requisition
Frozen=
All DIC and coagulation tests taken for the purposes of this study must be taken from an original stick or
venipuncture. All other blood tests may be taken from an existing port or line. To avoid clotting
cancellations, a small amount of blood must be collected from the venipuncture site before the blood is
drawn into the sodium citrate blue top tube.
Refrig=
Slides=
If early termination occurs before Day 14, check boxes and collect specimens for INR, D-Dimer,
Fibrinogen, DMI/Exploratory (Citrate), and DMII/Exploratory (EDTA).
Validation
YES
NO

First Entry
OPTIONAL TESTING refer to page 2 for collection and shipping instructions

Second Entry
Please check the box(es) to ensure proper ordering of optional test(s)! If you fail to mark the checkbox,
but return the container, all optional tests associated with the container will be ordered per Covance
policy.
INR
D-Dimer
Fibrinogen

Bar_req
Comments:
WHITE COPY-COVANCE
Bar_req
Label_6
510013
Af 070605
Page: 35
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
Page 2 of 2
2-part
Chemistry Panel
SMI/ART-123 Ab
THE FOLLOWING OPTIONAL SPECIMENS MUST BE SHIPPED FROZEN ON DRY ICE DAY OF COLLECTION:
WHITE COPY-COVANCE
Bar_req
Label_6
T 510013
Af 070605
Page: 36
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
VISIT: RETEST

Randomization #
Page 1 of 2
2-part
Covance
internal
use
ONLY
Employee Visa

Protocol: 2-001
Address_1
Address_2
Address_3
Address_4
Address_5
Address_6
Address_7
Site #
Pt #
Subject Initials
Kit #
First
Middle
Family/Last

used)
Collection Date
Day
Month
Year

Collection Time
24 Hour Clock
Phone number
Tube Count

requisition
Ambient=
All DIC and coagulation tests taken for the purposes of this study must be taken from an original stick or
venipuncture. All other blood tests may be taken from an existing port or line. To avoid clotting
cancellations, a small amount of blood must be collected from the venipuncture site before the blood is
drawn into the sodium citrate blue top tube.
Frozen=

Refrig=
YES
NO

Slides=
OPTIONAL TESTING refer to page 2 for collection and shipping instructions

Please check the box(es) to ensure proper ordering of optional test(s)! If you fail to mark the checkbox,
but return the container, all optional tests associated with the container will be ordered per Covance
policy.
Validation
First Entry
Chemistry Panel
Hematology II
DMIII/Thrombomodulin Level
INR
SMI/ART-123 Ab
D-Dimer
Second Entry
Fibrinogen

Bar_req
Comments:
WHITE COPY-COVANCE
Bar_req
Label_6
510013
Af 070605
Page: 37
510013_TMEA_Printed: 20070606

8211 SciCor Dr.
Tel: 800/327-7270
Fax: 317/616-2351
Bar_req
Accession No.
Requisition_n
Bar_req

COVANCE.
Page 2 of 2
2-part
THE FOLLOWING OPTIONAL SPECIMENS MUST BE SHIPPED AMBIENT DAY OF COLLECTION:
Chemistry Panel
Hematology & Differential Panel - Hematology II
THE FOLLOWING OPTIONAL SPECIMENS MUST BE SHIPPED FROZEN ON DRY ICE DAY OF COLLECTION:
SMI/ART-123 Ab
DMI/Exploratory (Citrate) - DMIII/Thrombomodulin Level
WHITE COPY-COVANCE
Bar_req
Label_6
U 510013
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510013_TMEA_Printed: 20070606
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510013_TMEA_Printed: 20070606
GENERAL INFORMATION FOR PACKAGING AND SHIPPING

!
Covance shipping material is designed in accordance with IATA regulations!
Consolidated Shipments
For your convenience, shipping materials provided by Covance are not protocol specific. Please consolidate
sample shipments of like condition (ambient or frozen) to Covance whenever possible.
Courier Pick-up Information
Prior to shipping your first specimens, we recommend that you call the courier to define your site as a new
pickup location for shipments to Covance. This will facilitate the process when you are ready for your first
shipment. Covance will be billed directly for all transportation costs.
Please be sure to inquire about your local service schedules and the latest time of day that you can call to
arrange for a pick-up. Timely pick-ups will ensure samples are shipped within stability for testing. (Refer to
Stabilities for Analytes in Section 1 of this manual.)
While most samples are specified to be shipped day of collection, we realize there are times when circumstances do not permit this to occur.
Late afternoon sample collection after last call-in or pick-up availability for courier service
Dry ice may not be available the same day as frozen sample collection
Pick-up is missed by courier service
In the event that samples cannot be shipped the day of collection, they should be stored under the condition
they are to be shipped. These samples should then be shipped to Covance CLS the very next day of
availability.
AMBIENT samples should remain at ambient temperature Do not refrigerate
REFRIGERATED samples should remain between 2C and 8C
FROZEN samples should remain frozen at the appropriate temperature
Refer to Stabilities for Analytes in Section 1 of this manual.
For Latin America, Australia, New Zealand and Asia:
When contacting courier, also inquire about local export requirements.
Shipping boxes
Containers must be securely packed in their shipping box. Please check by gently shaking the box after
packaging. If the containers are loose, repack the box by filling the empty spaces with paper.
Materials Safety Data Sheets
MSDS sheets for chemical products used in Covance studies may be accessed at the following website:
http://imv.complyplus.com/covance. The website allows you to search for the MSDS sheets by common name,
manufacturer and even print reports of all current items shown in our database.
English_General Information for Packaging and Shipping_Update: 20061017
2003 Covance CLS
Page: 40
510013_TMEA_Printed: 20070606
COURIER CONTACT NUMBERS

FOR US, CANADA AND PUERTO RICO
United States
DHL Express*
(888) 708-8825
Federal Express**
(800) 463-3339
World Courier**
(800) 221-6600
Canada
Federal Express
(800) 463-3339
World Courier
(800) 387-3381
Puerto Rico
Federal Express
(787) 793-9300
Japan__________________________________________
World Courier
81 3 3537-1080
* It is important to utilize the special 888 number when contacting DHL to schedule pick-ups. This is a
special number for Covance sites only. Scheduling pickups via their automated system or on the Internet
will circumvent all of the special procedures Covance has in place with DHL and increase the chances of
a missed pickup.
** Hawaii Sites Note: Covance Central Laboratory Services Logistics Department will track all shipments from
Hawaii. Please fax airbill number of shipment to 1-800-335-1462 so that tracking may occur. Shipments
should only be made Monday through Wednesday. Thursday shipments must be marked for Saturday
delivery.
2003 Covance CLS
English_US Courier Contact Numbers_Update: 20051101
Page: 41
510013_TMEA_Printed: 20070606
DANGEROUS GOODS TRAINING REQUIREMENTS

The investigator site is responsible for ensuring their staff is properly trained per their national regulations.
The changes to current regulations should be considered when assessing how training of staff fits into your
risk management program.
Dry Ice and other Dangerous Goods:
It is necessary for all individuals involved in the preparation or transport of dangerous goods to be properly
trained and tested initially, with follow-up training every 24 months. Additional training updates are required
any time the applicable regulations change.
Function specific training for preparing and shipping frozen samples on dry ice is a requirement.
Some chemical fixatives and UN2814 Category A Infectious substances require a more traditional training program to ensure compliance with national and international rule making governing the packing and
shipping of these substances.
UN3373 Biological Substance, Category B (formerly known as Diagnostic specimens):
Biological Substance, Catagory B are specimens being transported for "investigational purposes". Effective
01 January 2005, training requirements for persons responsible for packing and shipping Biological
Substance, Catagory B, UN3373, has been redefined in the International Civil Aviation Organization (ICAO)
Technical Instructions as well as the International Air Transport Association (IATA) dangerous goods regulations.
Comprehensive formal training normally associated with other dangerous goods has been eliminated
and replaced with the requirement for the shipper to be "familiar" with the specific regulations pertaining
to packing and shipping of Biological Substances, Catagory B.
Covance recommends that investigator sites provide some form of familiarization training to their staff for the
preparation and shipping of UN3373 Biological Substance, Catagory B. We also recommend establishing a
record of your staff's training and date of the instruction.
List of Dangerous Goods training programs
The following is a list of several available training programs. Covance does not advocate or endorse one particular program. This is not an all-inclusive list.
DGI Training Center

800-338-2291
DGItraining.com
Provides IATA Certified Air Seminars and
online courses
IATA Training Schools

North America 1(514)390-6726
Europe, Africa, & Middle East 41 (22) 799 2751
Asia, Australia & the Pacific 65 239 7232
www.iata.org/atdi
Training schools located in 30 countries
Saf-T Pak Inc.

www.saftpak.com
Provides dangerous goods training via CD
or on-site instruction for North America and
Europe
Airconsult
e-mail: Airconsult@wanadoo.fr
www.airconsult-bf.com
The training records must be made available upon request by the appropriate national authority.
US sites: Additional information from the Department of Transportation (DOT) can be found on their website,
http://hazmat.dot.gov
2005 Covance CLS
English_Dangerous Goods Training Requirements_Update: 20061208
Page: 42
510013_TMEA_Printed: 20070606
AMBIENT PACKAGING PROCEDURES

BIOLOGICAL SUBSTANCE, CATEGORY B

!
Notify your courier of your shipment!

Problems/questions concerning packaging procedures? Call us using our toll-free number.
1. Insert the tube(s) into the

Specimen Collection Bag containing an absorbent pack.
Place bag on flat surface to
minimize wrinkles, especially at
adhesive
sealing
area.
Remove tape liner to expose
adhesive. Fold along bag opening so star is inside of box
shape. Press from center to
edge to seal.
2. Fold the white copy of the completed requisition form and

place it into the pocket on the
reverse side of the Specimen
Collection Bag. The bar code
must be visible.
3. Take a Gel Pak and fill it to the

indicator line with cool tap
water. Seal the bag.
4. Lightly press the absorbent

pack to expel its contents.
Massage the bag until water
has been absorbed and a gel
materiel has formed.
5. Expel the air from the Gel Pak

and
reseal.
Place
the
Specimen Collection Bag on
top of the Gel Pak. Wrap the
Gel Pak around the Specimen
Collection Bag, sandwiching the
specimens in the middle. Do
not insert the specimen containers directly into the Gel
Pak!
6. Place the Gel Pak into the

white kit box.
7. Insert the kit into the zip bag.
8. Place the zip bag into the shipping carton. Fill empty spaces
with cushioning material (i.e.
paper).
English_Packaging Procedure Ambient_Update: 20060822
Continued on next page...

2003 Covance CLS
Page: 43
510013_TMEA_Printed: 20070606
Note:
If the kit box is too large to place
in the ambient shipping carton,
wrap a rubberband around the
Gel Pak. Place the Gel Pak containing the specimen collection
bag inside the large ziplock bag.
Place the zip bag into the shipping carton. Fill empty spaces
paper).
AMBIENT PACKAGING PROCEDURES

Continued from previous page
9. Seal the shipping carton

securely. Affix the label with
your address on the box as
indicated on the picture above.
10. US domestic shipments: Complete and affix the airbill to the designated spot on the box.
Rest of world: Insert the shipping documentation into the transparent pouch ensuring that the airbill remains visible. Affix the
pouch to the cardboard box on the Place airbill here section.
English_Packaging Procedure Ambient_Update: 20060822
2003 Covance CLS
Page: 44
510013_TMEA_Printed: 20070606
COMBINED AMBIENT- FROZEN PACKAGING PROCEDURES

Notify your courier of your shipment!

Problems/questions concerning packaging procedures? Call us using our toll-free number.
Ship no more than 10 specimens or 2 accession numbers for every 2.2 kilograms of dry ice!
1. Place the frozen tube(s) into a

Specimen Collection Bag containing an absorbent pack.
Place bag on flat surface to
minimize wrinkles, especially at
adhesive sealing area. Remove
tape liner to expose adhesive.
Fold along bag opening so star
is inside of box shape. Press
from center to edge to seal.
2. Fill half of the styrofoam container with dry ice and insert
the
Specimen
Collection
Bag(s). Then fill up the container using at least 2.2 kg dry
ice in total.
3. Replace the styrofoam lid.
4. Place the cardboard spacer

on top of the styrofoam.
5. For the ambient tubes, repeat

step 1. Then fold the white copy
of the completed requisition
form and place it into the pocket on the reverse side of the
Specimen Collection Bag. The
bar code must be visible.
6. Take a Gel Pak and fill it to the

indicator line with cool tap
water. Seal the bag.
7. Lightly press the absorbent

pack to expel its content.
Massage the bag until water
has been absorbed and a gel
materiel has formed. Expel the
air from the Gel Pak and
reseal.
8. Place the Specimen Collection

Bag on top of the Gel Pak.
Wrap the Gel Pak around the
Specimen Collection Bag, sandwiching the specimens in the
middle. Do not insert the
specimen containers directly
into the Gel Pak!
Continued on next page...
2003 Covance CLS
English_Packaging Procedure Combo Ambient Frozen 1/2_Update: 20061013
Page: 45
510013_TMEA_Printed: 20070606
COMBINED AMBIENT- FROZEN PACKAGING PROCEDURES

Continued from previous page...
9. Place the specimen collectin

bag wrapped in the Gel Pak
into the white kit box.
10. Insert the kit into the zip bag.
11.Place the zip bag into the cardboard box. Fill empty spaces
paper).
Note:
If the kit box is too large to place
in the ambient shipping carton,
wrap a rubberband around the
Gel Pak. Place the Gel Pak containing the specimen collection
bag inside the large ziplock bag.
Place the zip bag into the shipping carton. Fill empty spaces
paper).
12. Seal the carton with clear shipping tape.

Affix the label with your address on the box
as indicated on the picture above. Verify the
amount of dry ice in kilograms on the
UN1845 label.
13. Insert the shipping documentation (Airbill) into the

transparent pouch ensuring that the Airbill remains
visible. Affix the pouch to the shipping carton on the
Shipping documents section. Note that your shipment may be delayed if the label is not affixed to
the carton.
2003 Covance CLS
English_Packaging Procedure Combo Ambient Frozen 2/2_Update: 20061013
Page: 46
510013_TMEA_Printed: 20070606
SHIPPING DOCUMENTS
ARE PROVIDED IN LARGE COLOR-CODED ENVELOPES
The protocol specific shipping documents are provided in the appropriate envelope with the start-up
material. They are not automatically resupplied.
Order additional envelopes by using the resupply form provided in this manual or by contacting
Covance CLS.
The envelope with text in RED

contains your shipping documents
for ambient or refrigerated
Biological Substance, Category B
specimens.
The envelope with text in BLUE

contains your Covance provided
shipping documents for
- frozen Biological Substance
Category B specimens
- combo ambient-frozen Biological
Substance Category B specimens.
The envelope with

text in GREEN
contains your shipping
documents for
miscellaneous
(including any special
shipping documents
not included in the
two other envelopes)
and/or dangerous
goods specimens
2003 Covance CLS
English_Shipping Documents_Update: 20061208
Page: 47
510013_TMEA_Printed: 20070606
AMBIENT, REFRIGERATED SHIPPING DOCUMENTS

ress
ic add
inted
Prepr
with
ecif
site sp
You must enter:

A Senders signature
B Date
C Weight of package in pounds (record weight using whole numbers only)
D Saturday Delivery (if shipping on Friday)
Peel adhesive package label off of the last copy of the airbill and place on shipping carton.
When calling to schedule your pick-up, inform the dispatcher that your package is an URGENT COVANCE
MEDICAL SHIPMENT.
English_US Shipping Documents Ambient Airborne_Update: 20061208
2003 Covance CLS
Page: 48
510013_TMEA_Printed: 20070606
AMBIENT, REFRIGERATED SHIPPING DOCUMENTS

A
specific
h site
it
w
d
e
t
re-prin
addres
You must enter:

A Senders signature
B Saturday Delivery (if sent on Friday)
When calling to schedule your pick-up, inform the dispatcher that your package is an
URGENT COVANCE MEDICAL SHIPMENT.
English_US Shipping Documents Specimens Ambient FedEx Canada_Update: 20061208
Page: 49
510013_TMEA_Printed: 20070606
2003 Covance CLS
AMBIENT SHIPPING DOCUMENTS

inted
Prepr
ddres
cific a
spe
ith site
You must enter:

A
Write down appropriate airbill number
Write down total number of packages
Signature of shipper
Name Printed
Date
2003 Covance CLS
English_Canada Commercial Invoice Ambient Specimens_Update: 20061208
Page: 50
510013_TMEA_Printed: 20070606
FROZEN AND COMBINED AMBIENT-F

FROZEN SHIPPING DOCUMENTS
ecific
inted
Prepr
ite sp
with s
ss
addre
A
E
You must enter:

A Amount of dry ice in kilograms (record using whole numbers only, must match UN1845 label on box)
B Senders signature
C Date
D Weight of package in pounds (record weight using whole numbers only)
E Saturday Delivery (if shipping on Friday)
Peel adhesive package label off of the last copy of the airbill and place on shipping carton.
2003 Covance CLS
English_US Shipping Documents Frozen Airborne USA_Update: 20061208
Page: 51
510013_TMEA_Printed: 20070606
FROZEN AND COMBINED AMBIENT-F

A
specific
h site
it
w
d
e
t
re-prin
addres
B
C
You must enter:

A Senders signature
B Saturday Delivery (if sent on Friday)
C Amount of dry ice in kilograms (1 kilogram=2.2 pounds)
English_US Shipping Documents Diagnostic Specimens Frozen Combined FedEx Canada_Update: 20061208
Page: 52
510013_TMEA_Printed: 20070606
2003 Covance CLS

inted
Prepr
ddres
cific a
spe
ith site
You must enter:

A
Write down appropriate airbill number
Write down total number of packages
Signature of shipper
Name Printed
Date
2003 Covance CLS
English_Canada Commercial Invoice Frozen Specimens_Update: 20061208
Page: 53
510013_TMEA_Printed: 20070606
Page: 54
510013_TMEA_Printed: 20070606
SUPPLY/RESUPPLY
In your initial shipment, you will receive a start-up supply which is specific for your trial and your site.
For studies with automatic resupply
Scheduled visits required
When the patients first lab visit is received at Covance Central Laboratory Services, KMS sets up a delivery
schedule on all kits required for upcoming scheduled visits. This program ensures the kit supply based on the
evaluation of each patient and re-evaluates the delivery schedule based on the investigators activity or the
inventory adjustment.
Other visits
The first visit, skippable visits, retest/unscheduled, and early termination are kept at a pre-defined quantity. For
this reason, a minimum and a maximum limit is pre-defined for these types of visits. Once the inventory drops
below this quantity, KMS will trigger a resupply of kits. The pre-defined limit can be customized by request of
the investigator site by contacting the Kit Inventory Center at Covance.
There is no automatic resupply for Russia, India and Thailand, investigators in these countries are kindly
requested to contact Covance for resupply form. There is no supply of shipping boxes for Israel and Africa.
Investigators in these countries are kindly requested to order boxes to the courier each time they request a
pick-up.
Investigator sites need to actively monitor inventory of kits and shipping materials. It is crucial
that the inventories at the site are consistent with Covance automatic resupply. If you destroy or
have on your site expired kits, please contact the Kit Inventory Center in order to up-date our
schedule in accordance with your new inventory!
Each time you need more material, please contact:

Covance CLS in Indianapolis
Kit Inventory Management/Resupply
1-800-327-7270
All supply orders need to be faxed by 12:00 p.m. Eastern Standard Time in order to be processed the day of
the fax. Faxes received after 12:00 p.m. will be processed the following business day.
Please report any problems to Kit Inventory Management/Resupply at 1-800-327-7270.
Covance CLS in Geneva (for sites in Europe, Middle East and Africa)
Kit Inventory Center
Fax: + 41 22 989 1993 or + 41 22 989 1994
E-mail: resupply.emea@covance.com
Australia, New Zealand and Asia Sites
Sonic Clinical Trials in Australia
Investigator Services Department
Fax: + 61 2 9855 5419
Refer to your resupply form for number of days for delivery*

*If you are located in an extended delivery area, your delivery may be longer. Call Covance if you have
questions. There will be an expedited fee for orders requested with less than the standard turn around time.
English_Supply Resupply_Update: 20051114
2003 Covance CLS
Page: 55
510013_TMEA_Printed: 20070606
ADDITIONAL KITS / MATERIAL ORDER FORM

FOR US, CANADA, PUERTO RICO
Attn: Covance Central Laboratory Services, Kit Inventory Center

Fax: 317-616-2352
Please make a photocopy of this page before filling it in. Type or write legibly with a black ball pen
Principal Investigator at site:
____________________________________
Site Number:
____________________________________
Pharmaceutical Company: ____________________________
Protocol Number:
Name: _______________________________________________
Phone Number: _______________________
______________________________
Allow 7 working days for delivery*

*If you are located in an extended delivery area, your delivery may be longer. Call Covance if you have questions.
KIT
Visit number/Name
Shipping Boxes
Quantity
Quantity
Ambient boxes (Order by Case)

Frozen boxes
Refrigerated boxes
Reason
Expired
Lost
Not
Received
Stock
Insufficient
Shipping Documents
Quantity
On Hand
Quantity
Ambient shipping documents

(may also be used for refrigerated
shipments)
Frozen shipping documents
(may also be used for combined
ambient/frozen shipments)
Combined Ambient/Refrigerated boxes

Combined ambient/frozen boxes
Referral laboratory shipping documents
Referral laboratory boxes

Ambient Frozen Refrigerated
Other _____________________________
Other ______________________________
Other _____________________________
Stop Automatic resupply. Do not send

any more kits for the following visits:
Comments: _________________________________________
______________________________________________________
___________________________________________________________
______________________________________________________
___________________________________________________________
______________________________________________________
___________________________________________________________
______________________________________________________
___________________________________________________________
______________________________________________________
___________________________________________________________
______________________________________________________
2003 Covance CLS
English_US Resupply Form_Update: 20070216
Page: 56
510013_TMEA_Printed: 20070606
Page: 57
510013_TMEA_Printed: 20070606
REFERENCE RANGES/ALERTS AND FLAGS

The reference ranges are age, gender specific and represent a heterogeneous clinical trials patient
population. Flags are indicated in the laboratory report.
The unstated word to is implied by the dash appearing in age specific reference ranges. A range such as
0-59 years and 59-150 years means: 0 up to but not including 59 years and 59 up to but not including
150 years.
The H and L flags will always be printed. Your sponsor may request different or additional flags, other than
the ones listed below. Notification of the sponsor flags will occur only if requested by the sponsor.
Note: Reference ranges and alert flags included in the Investigator Manual are for reference purposes only.
Reference ranges and alert flags which are sex and/or age specific can change during the course of a
clinical trial. Therefore, reference ranges and alert flags that print on the Covance CLS laboratory
report should be used for patient management.
Flag
Represents
Meaning
Notification
H
L
High Flag
Low Flag
Patients result is outside of the

reference range.
No Notification
HT
LT
High Telephone
Low Telephone
Patients result is outside of the

reference range significantly
enough to warrant notification.
Investigator Site
HP
LP
High Panic
Low Panic
Patients result is outside

of the reference range with
potentially critical implications
for the patient.
Investigator Site
(and Sponsor
if requested)
+d
-d
Delta
Delta
Patients current result has

changed (delta) from the patients
baseline value.
No Notification
EX
Exclusions
Patients value is an exclusion

according to protocol
requirements. EX flags are
protocol specific. Investigator
should refer to the protocol to
validate the EX flag.
Investigator Site
(and Sponsor
if requested)
Reporting holds
Your laboratory reports will be held for data clarification when:
- Patient data on the requisition form is missing, incomplete, or inconsistent with previous records.
- Additional data requested on the requisition form is missing.
- A kit refers to a visit that has been received earlier or to a visit out of sequence.
When the issue has been clarified the laboratory report will be released. In case of a clinically
important alert, the investigator in question will be contacted immediately.
2003 Covance CLS
English_Reference Ranges/Alerts and Flags_Update: 20061103
Page: 58
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM
Artisan Pharmaceuticals, Inc.

Reference Range Report (Clinical)
Protocol: 2-001
Reported in: Conventional Units
Group: FIBRINOGEN
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
L
H
01-Mar-2007
Fibrinogen (CGT285)
Both
0Y-150Y
200-400 mg/dL
<200
>400
Key:
Alert flags:
H
L
High
Low
Covance CLS
Run: 6-Jun-07
2:47 PM
8211 SciCor Drive, Indianapolis, IN USA 46214-2985 (317) 271-1200 FAX (317) 616-2351

Protocol: 2-001
Group: INR
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
L
H
HT
28-Dec-2006
PT (CGT283)
Both
0Y-150Y
9.7-12.3 sec
<9.7
>12.3
>40.0
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
28-Dec-2006
INR (CGT286)
Key:
Alert flags:
Both
H
HP
HT
L
0Y-150Y
0.8-1.2
<0.8
>1.2
>3.0
>4.0
High
High Panic
High - Telephone
Low
Covance CLS
Page: 59
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Group: HEMATOLOGY& DIFFERENTIAL PANEL
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
23-Oct-2000
HGB (HMT40)
Female
0Y-1D
13.5-22.0 g/dL
<8.0
<10.0
<13.5
>22.0
1D-8D
13.5-22.0 g/dL
<8.0
<10.0
<13.5
>22.0
8D-15D
12.5-21.0 g/dL
<8.0
<10.0
<12.5
>21.0
15D-31D
10.0-20.0 g/dL
<8.0
<10.0
>20.0
31D-4M
10.0-14.0 g/dL
<8.0
<10.0
>14.0
4M-7M
10.0-14.0 g/dL
<8.0
<10.0
>14.0
7M-2Y
10.5-13.5 g/dL
<8.0
<10.5
>13.5
2Y-3Y
11.0-14.0 g/dL
<8.0
<11.0
>14.0
3Y-6Y
11.8-14.7 g/dL
<8.0
<11.8
>14.7
6Y-12Y
11.2-15.5 g/dL
<6.0
<9.0
<11.2
>15.5
>19.0
>21.0
12Y-59Y
11.6-16.4 g/dL
<6.0
<10.0
<11.6
>16.4
>19.0
>23.0
59Y-150Y 11.5-15.8 g/dL
<6.0
<10.0
<11.5
>15.8
>19.0
>23.0
Male
0Y-1D
13.5-22.0 g/dL
<8.0
<10.0
<13.5
>22.0
1D-8D
13.5-22.0 g/dL
<8.0
<10.0
<13.5
>22.0
8D-15D
12.5-21.0 g/dL
<8.0
<10.0
<12.5
>21.0
15D-31D
10.0-20.0 g/dL
<8.0
<10.0
>20.0
31D-4M
10.0-14.0 g/dL
<8.0
<10.0
>14.0
4M-7M
10.0-14.0 g/dL
<8.0
<10.0
>14.0
7M-2Y
10.5-13.5 g/dL
<8.0
<10.5
>13.5
2Y-3Y
11.0-14.0 g/dL
<8.0
<11.0
>14.0
3Y-6Y
11.0-14.5 g/dL
<8.0
<11.0
>14.5
6Y-12Y
11.2-15.5 g/dL
<6.0
<8.0
<11.2
>15.5
>19.0
>21.0
12Y-59Y
12.7-18.1 g/dL
<6.0
<10.0
<12.7
>18.1
>19.0
>23.0
59Y-150Y 12.5-17.0 g/dL
<6.0
<10.0
<12.5
>17.0
>19.0
>23.0
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
16-Oct-2000
HCT (HMT2)
Run: 6-Jun-07
2:47 PM
Female
0Y-1D
42-60 %
1D-8D
42-60 %
8D-15D
39-60 %
15D-31D
31-55 %
31D-4M
28-42 %
4M-7M
28-42 %
7M-2Y
33-40 %
2Y-3Y
33-42 %
3Y-6Y
35-44 %
6Y-12Y
34-44 %
12Y-59Y
34-48 %
59Y-150Y 34-48 %
Male
0Y-1D
42-60 %
1D-8D
42-60 %
8D-15D
39-60 %
15D-31D
31-55 %
31D-4M
28-42 %
4M-7M
28-42 %
7M-2Y
33-40 %
2Y-3Y
33-42 %
Covance CLS 8211 SciCor Drive, Indianapolis, IN USA
<24
<30
<42
<24
<30
<42
<24
<30
<39
<20
<24
<31
<20
<24
<28
<20
<24
<28
<20
<24
<33
<24
<28
<33
<28
<35
<28
<34
<28
<34
<28
<34
<24
<30
<42
<24
<30
<42
<24
<30
<39
<20
<24
<31
<20
<24
<28
<20
<24
<28
<20
<24
<33
<24
<28
<33
46214-2985 (317) 271-1200 FAX

Protocol: 2-001
>60
>65
>60
>65
>60
>65
>55
>60
>42
>55
>42
>55
>40
>50
>42
>50
>44
>50
>44
>50
>48
>50
>48
>50
>60
>65
>60
>65
>60
>65
>55
>60
>42
>55
>42
>55
>40
>50
>42
>50
(317) 616-2351
Page:
2
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
16-Oct-2000
Continued...
HCT (HMT2)
Male
3Y-6Y
33-43 %
<24
<28
<33
>43
>50
6Y-12Y
34-44 %
<24
<34
>44
>50
12Y-59Y
39-54 %
<24
<39
>54
>55
59Y-150Y 37-51 %
<24
<37
>51
>55
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
16-Jan-2004
WBC (HMT7)
Female
0D-15D
8.30-17.60 x10E3/uL
<1.00
<4.00
<8.30
>17.60
>30.00
>50.00
15D-31D
6.90-15.00 x10E3/uL
<1.00
<3.00
<6.90
>15.00
>30.00
>50.00
31D-61D
6.10-13.80 x10E3/uL
<1.00
<3.00
<6.10
>13.80
>25.00
>30.00
61D-7M
6.80-16.20 x10E3/uL
<1.00
<3.00
<6.80
>16.20
>20.00
>30.00
7M-2Y
6.40-15.50 x10E3/uL
<1.00
<3.00
<6.40
>15.50
>20.00
>30.00
2Y-6Y
5.50-12.50 x10E3/uL
<1.00
<3.00
<5.50
>12.50
>15.00
>30.00
6Y-12Y
4.35-13.65x10E3/uL
<1.00
<2.00
<4.35
>13.65
>15.00
>30.00
12Y-18Y
4.35-13.15x10E3/uL
<1.00
<2.00
<4.35
>13.15
>15.00
>30.00
18Y-59Y
3.80-10.70 x10E3/uL
<1.00
<2.50
<3.80
>10.70
>15.00
>30.00
59Y-150Y 3.80-10.70 x10E3/uL
<1.00
<2.50
<3.80
>10.70
>15.00
>30.00
Male
0D-15D
8.60-14.90 x10E3/uL
<1.00
<4.00
<8.60
>14.90
>30.00
>50.00
15D-31D
7.40-13.30 x10E3/uL
<1.00
<3.00
<7.40
>13.30
>30.00
>50.00
31D-61D
6.00-13.70 x10E3/uL
<1.00
<3.00
<6.00
>13.70
>25.00
>30.00
61D-7M
6.60-15.60 x10E3/uL
<1.00
<3.00
<6.60
>15.60
>20.00
>30.00
7M-2Y
6.30-15.40 x10E3/uL
<1.00
<3.00
<6.30
>15.40
>20.00
>30.00
2Y-6Y
5.50-12.30 x10E3/uL
<1.00
<3.00
<5.50
>12.30
>15.00
>30.00
6Y-12Y
4.35-13.65x10E3/uL
<1.00
<2.00
<4.35
>13.65
>15.00
>30.00
12Y-18Y
4.35-13.15x10E3/uL
<1.00
<2.00
<4.35
>13.15
>15.00
>30.00
18Y-59Y
3.80-10.70 x10E3/uL
<1.00
<2.50
<3.80
>10.70
>15.00
>30.00
59Y-150Y 3.80-10.70 x10E3/uL
<1.00
<2.50
<3.80
>10.70
>15.00
>30.00
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
26-Dec-2000
Neutrophil (HMT8)
Female
0D-1D
6.00-26.00 x10E3/uL
<1.00
<6.00
>26.00
>40.00
1D-8D
2.00-21.00 x10E3/uL
<1.00
<2.00
>21.00
>40.00
8D-15D
1.00-10.00 x10E3/uL
<0.50
<1.00
>10.00
>40.00
15D-31D
1.00-9.50 x10E3/uL
<0.50
<1.00
>9.50
>11.00
31D-4M
1.00-9.00 x10E3/uL
<0.50
<1.00
>9.00
>11.00
4M-7M
1.00-9.00 x10E3/uL
<0.50
<1.00
>9.00
>11.00
7M-2Y
1.50-9.60 x10E3/uL
<0.50
<1.00
<1.50
>9.60
>12.00
2Y-3Y
1.00-9.00 x10E3/uL
<0.50
<1.00
>9.00
>11.00
3Y-6Y
1.00-9.00 x10E3/uL
<0.50
<1.00
>9.00
>11.00
6Y-12Y
1.35-8.15 x10E3/uL
<0.50
<1.00
<1.35
>8.15
>11.00
12Y-18Y
1.65-8.15 x10E3/uL
<0.50
<1.00
<1.65
>8.15
>11.00
18Y-59Y
1.96-7.23 x10E3/uL
<0.50
<1.00
<1.96
>7.23
>11.00
59Y-150Y 1.96-7.23 x10E3/uL
<0.50
<1.00
<1.96
>7.23
>11.00
Male
0D-1D
6.00-26.00 x10E3/uL
<1.00
<6.00
>26.00
>40.00
1D-8D
2.00-21.00 x10E3/uL
<1.00
<2.00
>21.00
>40.00
8D-15D
1.00-10.00 x10E3/uL
<0.50
<1.00
>10.00
>40.00
Covance CLS 8211 SciCor Drive, Indianapolis, IN USA 46214-2985 (317) 271-1200 FAX (317) 616-2351
Page: 60
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
3
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
26-Dec-2000
Continued...
Neutrophil (HMT8)
Male
15D-31D
1.00-9.50 x10E3/uL
<0.50
<1.00
>9.50
>11.00
31D-4M
1.00-9.00 x10E3/uL
<0.50
<1.00
>9.00
>11.00
4M-7M
1.00-9.00 x10E3/uL
<0.50
<1.00
>9.00
>11.00
7M-2Y
1.50-9.40 x10E3/uL
<0.50
<1.00
<1.50
>9.40
>12.00
2Y-3Y
1.35-8.65 x10E3/uL
<0.50
<1.00
<1.35
>8.65
>11.00
3Y-6Y
1.35-8.65 x10E3/uL
<0.50
<1.00
<1.35
>8.65
>11.00
6Y-12Y
1.35-8.15 x10E3/uL
<0.50
<1.00
<1.35
>8.15
>11.00
12Y-18Y
1.65-8.15 x10E3/uL
<0.50
<1.00
<1.65
>8.15
>11.00
18Y-59Y
1.96-7.23 x10E3/uL
<0.50
<1.00
<1.96
>7.23
>11.00
59Y-150Y 1.96-7.23 x10E3/uL
<0.50
<1.00
<1.96
>7.23
>11.00
__________________________________________________________________________________________________________________________________________________________
H
29-Sep-1993
Bands (HMT20)
Both
0Y-150Y
0.00-0.27 x10E3/uL
>0.27
__________________________________________________________________________________________________________________________________________________________
LT
L
H
HT
26-Dec-2000
Lymphocyte (HMT9)
Female
Male
Covance CLS
Run: 6-Jun-07
2:47 PM
0D-1D
1D-8D
8D-15D
15D-31D
31D-4M
4M-7M
7M-2Y
2Y-3Y
3Y-6Y
6Y-12Y
12Y-18Y
18Y-59Y
59Y-150Y
0D-1D
1D-8D
8D-15D
15D-31D
31D-4M
4M-7M
7M-2Y
2Y-3Y
3Y-6Y
6Y-12Y
12Y-18Y
18Y-59Y
59Y-150Y
2.00-11.00 x10E3/uL
2.00-17.00 x10E3/uL
2.00-17.00 x10E3/uL
2.50-17.00 x10E3/uL
2.50-16.00 x10E3/uL
3.00-15.00 x10E3/uL
1.70-6.70 x10E3/uL
1.50-10.00 x10E3/uL
1.50-8.00 x10E3/uL
1.15-6.65 x10E3/uL
0.95-5.25 x10E3/uL
0.91-4.28 x10E3/uL
0.80-3.00 x10E3/uL
2.00-11.00 x10E3/uL
2.00-17.00 x10E3/uL
2.00-17.00 x10E3/uL
2.50-17.00 x10E3/uL
2.50-16.00 x10E3/uL
3.00-15.00 x10E3/uL
1.70-6.50 x10E3/uL
1.50-10.00 x10E3/uL
1.50-8.00 x10E3/uL
1.15-6.65 x10E3/uL
0.95-5.25 x10E3/uL
0.91-4.28 x10E3/uL
0.80-3.00 x10E3/uL
<0.50
<0.50
<0.50
<0.50
<0.50
<0.50
<1.30
<1.00
<1.00
<0.50
<0.50
<0.50
<0.50
<0.50
<0.50
<1.30
<1.00
<1.00
<2.00
<2.00
<2.00
<2.50
<2.50
<3.00
<1.70
<1.50
<1.50
<1.15
<0.95
<0.91
<0.80
<2.00
<2.00
<2.00
<2.50
<2.50
<3.00
<1.70
<1.50
<1.50
<1.15
<0.95
<0.91
<0.80
>11.00
>17.00
>17.00
>17.00
>16.00
>15.00
>6.70
>10.00
>8.00
>6.65
>5.25
>4.28
>3.00
>11.00
>17.00
>17.00
>17.00
>16.00
>15.00
>6.50
>10.00
>8.00
>6.65
>5.25
>4.28
>3.00
>25.00
>25.00
>25.00
>25.00
>25.00
>25.00
>10.00
>25.00
>25.00
>25.00
>25.00
>25.00
>25.00
>25.00
>25.00
>10.00
>25.00
>25.00

Protocol: 2-001
Page:
4
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
L
H
13-Jul-2006
Monocytes (HMT10)
Female
0D-4D
0.20-2.20 x10E3/uL
<0.20
>2.20
4D-8D
0.20-2.20 x10E3/uL
<0.20
>2.20
8D-15D
0.10-2.90 x10E3/uL
<0.10
>2.90
15D-31D
0.20-5.00 x10E3/uL
<0.20
>5.00
31D-61D
0.20-2.10 x10E3/uL
<0.20
>2.10
61D-180D 0.60-1.90 x10E3/uL
<0.60
>1.90
180D-2Y
0.30-1.50 x10E3/uL
<0.30
>1.50
2Y-6Y
0.50-1.10 x10E3/uL
<0.50
>1.10
6Y-12Y
0.40-0.90 x10E3/uL
<0.40
>0.90
12Y-18Y
0.40-0.90 x10E3/uL
<0.40
>0.90
18Y-150Y 0.12-0.92 x10E3/uL
<0.12
>0.92
Male
0D-4D
0.20-1.80 x10E3/uL
<0.20
>1.80
4D-8D
0.20-2.20 x10E3/uL
<0.20
>2.20
8D-15D
0.30-3.00 x10E3/uL
<0.30
>3.00
15D-31D
0.20-3.50 x10E3/uL
<0.20
>3.50
31D-61D
0.30-2.70 x10E3/uL
<0.30
>2.70
61D-180D 0.50-1.90 x10E3/uL
<0.50
>1.90
180D-2Y
0.40-2.00 x10E3/uL
<0.40
>2.00
2Y-6Y
0.30-1.20 x10E3/uL
<0.30
>1.20
6Y-12Y
0.30-0.90 x10E3/uL
<0.30
>0.90
12Y-18Y
0.40-1.30 x10E3/uL
<0.40
>1.30
18Y-150Y 0.12-0.92 x10E3/uL
<0.12
>0.92
__________________________________________________________________________________________________________________________________________________________
H
13-Jul-2006
Eosinophil (HMT11)
Female
0D-4D
0.00-0.20 x10E3/uL
>0.20
4D-8D
0.00-0.50 x10E3/uL
>0.50
8D-15D
0.00-0.60 x10E3/uL
>0.60
15D-31D
0.00-0.50 x10E3/uL
>0.50
31D-61D
0.00-0.20 x10E3/uL
>0.20
61D-180D 0.00-0.10 x10E3/uL
>0.10
180D-2Y
0.00-0.20 x10E3/uL
>0.20
2Y-6Y
0.00-0.20 x10E3/uL
>0.20
6Y-12Y
0.00-0.20 x10E3/uL
>0.20
12Y-18Y
0.00-0.20 x10E3/uL
>0.20
18Y-150Y 0.00-0.57 x10E3/uL
>0.57
Male
0D-4D
0.00-0.30 x10E3/uL
>0.30
4D-8D
0.00-0.80 x10E3/uL
>0.80
8D-15D
0.00-0.60 x10E3/uL
>0.60
15D-31D
0.00-0.90 x10E3/uL
>0.90
31D-61D
0.00-0.50 x10E3/uL
>0.50
61D-180D 0.00-0.40 x10E3/uL
>0.40
180D-2Y
0.00-0.30 x10E3/uL
>0.30
2Y-6Y
0.00-0.20 x10E3/uL
>0.20
6Y-12Y
0.00-0.30 x10E3/uL
>0.30
12Y-18Y
0.00-0.30 x10E3/uL
>0.30
18Y-150Y 0.00-0.57 x10E3/uL
>0.57
Page: 61
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
5
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
29-Sep-1993
Basophils (HMT12)
Both
0Y-150Y
0.00-0.20 x10E3/uL
>0.20
__________________________________________________________________________________________________________________________________________________________
L
H
09-Sep-1993
Neutrophil (HMT15)
Both
0Y-150Y
40.5-75.0 %
<40.5
>75.0
__________________________________________________________________________________________________________________________________________________________
H
18-Aug-1993
Bands (HMT21)
Both
0Y-150Y
0.0-3.0 %
>3.0
__________________________________________________________________________________________________________________________________________________________
L
H
02-Jun-1993
Lymphocyte (HMT16)
Both
0Y-150Y
15.4-48.5%
<15.4
>48.5
__________________________________________________________________________________________________________________________________________________________
L
H
13-Jul-2006
Monocytes (HMT17)
Female
0D-4D
5.0-11.0 %
<5.0
>11.0
4D-8D
6.0-14.0 %
<6.0
>14.0
8D-15D
6.0-19.0 %
<6.0
>19.0
15D-31D
5.0-14.0 %
<5.0
>14.0
31D-61D
5.0-14.0 %
<5.0
>14.0
61D-180D 4.0-12.0 %
<4.0
>12.0
180D-2Y
4.0-9.0 %
<4.0
>9.0
2Y-6Y
4.0-8.0 %
<4.0
>8.0
6Y-12Y
4.0-7.0 %
<4.0
>7.0
12Y-18Y
4.0-7.0 %
<4.0
>7.0
18Y-150Y 2.6-10.1 %
<2.6
>10.1
Male
0D-4D
4.0-13.0 %
<4.0
>13.0
4D-8D
7.0-17.0 %
<7.0
>17.0
8D-15D
7.0-18.0 %
<7.0
>18.0
15D-31D
6.0-18.0 %
<6.0
>18.0
31D-61D
6.0-17.0 %
<6.0
>17.0
61D-180D 4.0-11.0 %
<4.0
>11.0
180D-2Y
1.0-10.0 %
<1.0
>10.0
2Y-6Y
4.0-9.0 %
<4.0
>9.0
6Y-12Y
4.0-8.0 %
<4.0
>8.0
12Y-18Y
4.0-8.0 %
<4.0
>8.0
18Y-150Y 2.6-10.1 %
<2.6
>10.1
__________________________________________________________________________________________________________________________________________________________
H
13-Jul-2006
Eosinophil (HMT18)
Female
Covance CLS
Run: 6-Jun-07
2:47 PM
0D-4D
0.0-3.9 %
>3.9
4D-8D
0.0-7.5 %
>7.5
8D-15D
0.0-4.1 %
>4.1
15D-31D
0.0-5.4 %
>5.4
31D-61D
0.0-3.1 %
>3.1
61D-180D 0.0-2.8 %
>2.8

Protocol: 2-001
Page:
6
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
13-Jul-2006
Continued...
Eosinophil (HMT18)
Female
180D-2Y
0.0-3.1 %
>3.1
2Y-6Y
0.0-3.3 %
>3.3
6Y-12Y
0.0-4.0 %
>4.0
12Y-18Y
0.0-4.1 %
>4.1
18Y-150Y 0.0-6.8 %
>6.8
Male
0D-4D
0.0-2.9 %
>2.9
4D-8D
0.0-5.4 %
>5.4
8D-15D
0.0-5.0 %
>5.0
15D-31D
0.0-7.0 %
>7.0
31D-61D
0.0-5.4 %
>5.4
61D-180D 0.0-3.5 %
>3.5
180D-2Y
0.0-2.0 %
>2.0
2Y-6Y
0.0-2.4 %
>2.4
6Y-12Y
0.0-4.8 %
>4.8
12Y-18Y
0.0-2.8 %
>2.8
18Y-150Y 0.0-6.8 %
>6.8
__________________________________________________________________________________________________________________________________________________________
H
13-Jul-2006
Basophils (HMT19)
0D-4D
0.0-1.0 %
>1.0
4D-8D
0.0-1.0 %
>1.0
8D-15D
0.0-1.0 %
>1.0
15D-31D
0.0-1.0 %
>1.0
31D-61D
0.0-1.0 %
>1.0
61D-180D 0.0-1.0 %
>1.0
180D-2Y
0.0-1.0 %
>1.0
2Y-6Y
0.0-1.0 %
>1.0
6Y-12Y
0.0-1.0 %
>1.0
12Y-18Y
0.0-1.0 %
>1.0
18Y-150Y 0.0-2.0 %
>2.0
Male
0D-4D
0.0-1.0 %
>1.0
4D-8D
0.0-1.0 %
>1.0
8D-15D
0.0-1.0 %
>1.0
15D-31D
0.0-1.0 %
>1.0
31D-61D
0.0-1.0 %
>1.0
61D-180D 0.0-1.0 %
>1.0
180D-2Y
0.0-1.0 %
>1.0
2Y-6Y
0.0-1.0 %
>1.0
6Y-12Y
0.0-1.0 %
>1.0
12Y-18Y
0.0-1.0 %
>1.0
18Y-150Y 0.0-2.0 %
>2.0
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
26-Apr-1995
Platelets (HMT13)
Female
Female
Covance CLS
0D-1D
200-400 x10E3/uL
<100
<110
<200
>400
>600
1D-8D
200-400 x10E3/uL
<100
<110
<200
>400
>600
Page: 62
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
7
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
26-Apr-1995
Continued...
Platelets (HMT13)
Female
8D-15D
200-400 x10E3/uL
<100
<110
<200
>400
>600
15D-31D
200-400 x10E3/uL
<100
<110
<200
>400
>600
31D-4M
200-400 x10E3/uL
<100
<110
<200
>400
>600
4M-7M
200-400 x10E3/uL
<100
<110
<200
>400
>600
7M-2Y
200-400 x10E3/uL
<100
<110
<200
>400
>600
2Y-3Y
252-582 x10E3/uL
<100
<110
<252
>582
>600
3Y-6Y
240-570 x10E3/uL
<100
<110
<240
>570
>600
6Y-12Y
130-394 x10E3/uL
<100
<110
<130
>394
>600
12Y-60Y
140-400 x10E3/uL
<100
<110
<140
>400
>600
60Y-150Y 130-394 x10E3/uL
<100
<110
<130
>394
>600
Male
0D-1D
200-400 x10E3/uL
<100
<110
<200
>400
>600
1D-8D
200-400 x10E3/uL
<100
<110
<200
>400
>600
8D-15D
200-400 x10E3/uL
<100
<110
<200
>400
>600
15D-31D
200-400 x10E3/uL
<100
<110
<200
>400
>600
31D-4M
200-400 x10E3/uL
<100
<110
<200
>400
>600
4M-7M
200-400 x10E3/uL
<100
<110
<200
>400
>600
7M-2Y
200-400 x10E3/uL
<100
<110
<200
>400
>600
2Y-3Y
252-582 x10E3/uL
<100
<110
<252
>582
>600
3Y-6Y
240-570 x10E3/uL
<100
<110
<240
>570
>600
6Y-12Y
130-394 x10E3/uL
<100
<110
<130
>394
>600
12Y-60Y
140-400 x10E3/uL
<100
<110
<140
>400
>600
60Y-150Y 130-394 x10E3/uL
<100
<110
<130
>394
>600
Key:
Alert flags:
H
HP
HT
L
LP
LT
High
High Panic
High - Telephone
Low
Low Panic
Low - Telephone
Covance CLS
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Group: WBC MORPHOLOGY
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Blasts (HMT97)
Both
0Y-150Y
0%
>0
Key:
Alert flags:
HT
High - Telephone
Covance CLS
Page: 63
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Metamyelo (HMT69)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Myelocyte (HMT68)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Promyelocy (HMT67)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Myeloblast (HMT66)
Key:
Alert flags:
Both
H
HT
0Y-150Y
0%
>0
High
High - Telephone
Covance CLS
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Prolymph (HMT56)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Ly,Immunob (HMT59)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Ly,Plasmcy (HMT60)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Lymph,Reac (HMT61)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Lymphoblas (HMT62)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Atyp Lymph (HMT96)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Lymphoma C (HMT55)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Sezary, % (HMT57)
Key:
Alert flags:
Both
H
HT
0Y-150Y
0%
>0
High
High - Telephone
Covance CLS
Page: 64
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Promonocyt (HMT63)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Mono,Immat (HMT65)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Monoblast (HMT64)
Key:
Alert flags:
Both
H
HT
0Y-150Y
0%
>0
High
High - Telephone
Covance CLS
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
14-Feb-1997
Eos,Immat (HMT49)
Both
0Y-150Y
0%
>0
Key:
Alert flags:
High
Covance CLS
Page: 65
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
18-Jul-1994
Baso,Immat (HMT48)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Plasma Pre (HMT52)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
14-Feb-1997
Plasma Imm (HMT53)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Plasma Cel (HMT54)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Malign,Nos (HMT50)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Hairy Cell (HMT58)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
NRBC (HMT70)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
18-Sep-1992
CBC Commt: (HMT51)
Both
0Y-150Y
Key:
Alert flags:
H
HT
High
High - Telephone
Covance CLS
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Blasts (HMT94)
Both
0Y-150Y
0 x10E3/uL
>0.00
Key:
Alert flags:
HT
High - Telephone
Covance CLS
Page: 66
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Metamyelo (HMT93)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Myelocyte (HMT92)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Promyelocy (HMT91)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Myeloblast (HMT90)
Key:
Alert flags:
Both
H
HT
0Y-150Y
0 x10E3/uL
>0.00
High
High - Telephone
Covance CLS
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Prolymph (HMT81)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Ly,Immunob (HMT83)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Ly,Plasmcy (HMT84)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Lymph,Reac (HMT85)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Lymphoblas (HMT86)
Both
0Y-150Y
0 x10E3/uL
>0.00
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Atyp Lymph (HMT95)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Lymphoma C (HMT80)
Both
0Y-150Y
0 x10E3/uL
>0.00
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Sezary,Abs (HMT72)
Key:
Alert flags:
Both
H
HT
0Y-150Y
0 X10E3/uL
>0
High
High - Telephone
Covance CLS
Page: 67
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Promonocyt (HMT87)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Mono,Immat (HMT89)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Monoblast (HMT88)
Key:
Alert flags:
Both
H
HT
0Y-150Y
0 x10E3/uL
>0.00
High
High - Telephone
Covance CLS
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Eos,Immat (HMT75)
Both
0Y-150Y
x10E3/uL
>0
0
Key:
Alert flags:
High
Covance CLS
Page: 68
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Baso,Immat (HMT74)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Plasma Pre (HMT77)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Plasma Imm (HMT78)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Plasma Cel (HMT79)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Malign,NOS (HMT76)
Both
0Y-150Y
0 x10E3/uL
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Hairy Cell (HMT82)
Both
0Y-150Y
0 x10E3/uL
>0.00
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
NRBC (HMT98)
Both
0Y-150Y
0%
>0.00
__________________________________________________________________________________________________________________________________________________________
09-Dec-1992
CBC Commt: (HMT99)
Both
0Y-150Y
Key:
Alert flags:
H
HT
High
High - Telephone
Covance CLS
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Group: HEMATOLOGY II
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
26-Apr-1995
Platelets (HMT13)
Female
0D-1D
200-400 x10E3/uL
<100
<110
<200
>400
>600
1D-8D
200-400 x10E3/uL
<100
<110
<200
>400
>600
8D-15D
200-400 x10E3/uL
<100
<110
<200
>400
>600
15D-31D
200-400 x10E3/uL
<100
<110
<200
>400
>600
31D-4M
200-400 x10E3/uL
<100
<110
<200
>400
>600
4M-7M
200-400 x10E3/uL
<100
<110
<200
>400
>600
7M-2Y
200-400 x10E3/uL
<100
<110
<200
>400
>600
2Y-3Y
252-582 x10E3/uL
<100
<110
<252
>582
>600
3Y-6Y
240-570 x10E3/uL
<100
<110
<240
>570
>600
6Y-12Y
130-394 x10E3/uL
<100
<110
<130
>394
>600
12Y-60Y
140-400 x10E3/uL
<100
<110
<140
>400
>600
60Y-150Y 130-394 x10E3/uL
<100
<110
<130
>394
>600
Male
0D-1D
200-400 x10E3/uL
<100
<110
<200
>400
>600
1D-8D
200-400 x10E3/uL
<100
<110
<200
>400
>600
8D-15D
200-400 x10E3/uL
<100
<110
<200
>400
>600
15D-31D
200-400 x10E3/uL
<100
<110
<200
>400
>600
31D-4M
200-400 x10E3/uL
<100
<110
<200
>400
>600
4M-7M
200-400 x10E3/uL
<100
<110
<200
>400
>600
7M-2Y
200-400 x10E3/uL
<100
<110
<200
>400
>600
2Y-3Y
252-582 x10E3/uL
<100
<110
<252
>582
>600
3Y-6Y
240-570 x10E3/uL
<100
<110
<240
>570
>600
6Y-12Y
130-394 x10E3/uL
<100
<110
<130
>394
>600
12Y-60Y
140-400 x10E3/uL
<100
<110
<140
>400
>600
60Y-150Y 130-394 x10E3/uL
<100
<110
<130
>394
>600
Key:
Alert flags:
H
HT
L
LP
LT
High
High - Telephone
Low
Low Panic
Low - Telephone
Covance CLS
Page: 69
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Group: D-DIMER
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
HT
20-Apr-2007
D-Dimer (IMT1209)
Both
0Y-18Y
ng/mL(FEU)
No Ref Rng
18Y-150Y <500 ng/mL(FEU)
>499.999999
Key:
Alert flags:
HT
High - Telephone
Covance CLS
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Group: CHEMISTRY PANEL
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
22-Mar-2001
Total Bili (RCT1)
Both
0W-2W
0.2-11.7 mg/dL
<0.2
>11.7
>20.0
2W-18Y
0.2-1.2 mg/dL
<0.2
>1.2
>2.0
>3.0
18Y-150Y 0.2-1.2 mg/dL
<0.2
>1.2
>2.0
>3.0
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
24-Jan-2003
Alk Phos (RCT1407)
Female
0M-1M
48-406 U/L
<48
>406
>500
>750
1M-1Y
124-341 U/L
<124
>341
>500
>750
1Y-4Y
108-317 U/L
<108
>317
>500
>750
4Y-7Y
96-297 U/L
<96
>297
>500
>750
7Y-10Y
69-325 U/L
<69
>325
>500
>750
10Y-15Y
51-300 U/L
<51
>300
>400
>750
15Y-18Y
31-110 U/L
<31
>110
>200
>500
18Y-50Y
31-106 U/L
<31
>106
>200
>500
50Y-60Y
35-123 U/L
<35
>123
>300
>500
60Y-70Y
35-123 U/L
<35
>123
>300
>500
70Y-80Y
35-135 U/L
<35
>135
>300
>500
80Y-90Y
35-135 U/L
<35
>135
>300
>500
90Y-150Y 35-140 U/L
<35
>140
>300
>500
Male
0M-1M
75-316 U/L
<75
>316
>500
>750
1M-1Y
82-383 U/L
<82
>383
>500
>750
1Y-4Y
104-345 U/L
<104
>345
>500
>750
4Y-7Y
93-309 U/L
<93
>309
>500
>750
7Y-10Y
86-315 U/L
<86
>315
>500
>750
10Y-15Y
95-385 U/L
<95
>385
>500
>750
15Y-18Y
50-250 U/L
<50
>250
>300
>750
18Y-50Y
31-129 U/L
<31
>129
>250
>500
50Y-60Y
35-131 U/L
<35
>131
>300
>500
60Y-70Y
35-125 U/L
<35
>125
>300
>500
70Y-80Y
35-130 U/L
<35
>130
>300
>500
80Y-90Y
35-125 U/L
<35
>125
>300
>500
90Y-150Y 35-125 U/L
<35
>125
>300
>500
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
23-Nov-2004
ALT (SGPT) (RCT4)
Female
0Y-1Y
<=54 U/L
1Y-4Y
6-34 U/L
4Y-7Y
6-34 U/L
7Y-10Y
6-34 U/L
10Y-18Y
6-34 U/L
18Y-69Y
6-34 U/L
69Y-150Y 6-32 U/L
Male
0Y-1Y
<=54 U/L
1Y-4Y
6-34 U/L
4Y-7Y
6-34 U/L
7Y-10Y
6-34 U/L
10Y-18Y
6-43 U/L
>54
>100
>200
>34
>100
>200
>34
>100
>200
>34
>100
>200
>34
>200
>300
>34
>200
>300
>32
>200
>300
>54
>100
>200
<6
>34
>100
>200
<6
>34
>100
>200
<6
>34
>100
>200
<6
>43
>200
>300
46214-2985 (317) 271-1200 FAX (317) 616-2351
<6
<6
<6
<6
<6
<6
Page: 70
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
2
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
23-Nov-2004
Continued...
ALT (SGPT) (RCT4)
Male
18Y-69Y
6-43 U/L
<6
>43
>200
>300
69Y-150Y 6-35 U/L
<6
>35
>200
>300
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
27-Dec-2000
AST (SGOT) (RCT5)
Female
0Y-1Y
10-80 U/L
<10
>80
>200
>300
1Y-4Y
10-56 U/L
<10
>56
>100
>200
4Y-7Y
10-48 U/L
<10
>48
>100
>200
7Y-18Y
10-40 U/L
<10
>40
>100
>200
18Y-59Y
9-34 U/L
<9
>34
>200
>300
59Y-150Y 9-34 U/L
<9
>34
>200
>300
Male
0Y-1Y
10-80 U/L
<10
>80
>200
>300
1Y-4Y
10-69 U/L
<10
>69
>100
>200
4Y-7Y
10-59 U/L
<10
>59
>100
>200
7Y-18Y
10-40 U/L
<10
>40
>100
>200
18Y-59Y
11-36 U/L
<11
>36
>200
>300
59Y-150Y 11-36 U/L
<11
>36
>200
>300
__________________________________________________________________________________________________________________________________________________________
L
H
HP
24-Jan-2003
LDH (RCT1408)
Female
Urea Nitr (RCT6)
Both
0M-1M
145-765 U/L
<145
>765
>1000
1M-1Y
190-420 U/L
<190
>420
>1000
1Y-3Y
165-395 U/L
<165
>395
>500
3Y-6Y
135-345 U/L
<135
>345
>500
6Y-9Y
140-280 U/L
<140
>280
>500
9Y-12Y
120-260 U/L
<120
>260
>500
12Y-15Y
100-275 U/L
<100
>275
>500
15Y-18Y
105-230 U/L
<105
>230
>500
18Y-150Y 53-234 U/L
<53
>234
>350
Male
0M-1M
125-735 U/L
<125
>735
>1000
1M-1Y
170-450 U/L
<170
>450
>1000
1Y-3Y
155-345 U/L
<155
>345
>500
3Y-6Y
155-345 U/L
<155
>345
>500
6Y-9Y
145-300 U/L
<145
>300
>500
9Y-12Y
120-325 U/L
<120
>325
>500
12Y-15Y
120-290 U/L
<120
>290
>500
15Y-18Y
105-235 U/L
<105
>235
>500
18Y-150Y 53-234 U/L
<53
>234
>350
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
25-Jun-2005
Covance CLS
Run: 6-Jun-07
2:47 PM
0Y-18Y
18Y-70Y
70Y-80Y
80Y-150Y
4-24
4-24
4-29
4-34
mg/dL
mg/dL
mg/dL
mg/dL
<4
<4
<4
<4
>24
>24
>29
>34
>35
>35
>40
>40
>50
>50
>50
>50

Protocol: 2-001
Page:
3
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
24-Aug-2000
Creatinine (RCT392)
Female
0M-1M
0.2-0.6 mg/dL
<0.2
>0.6
>1.0
>1.5
1M-1Y
0.1-0.3 mg/dL
<0.1
>0.3
>1.0
>1.5
1Y-4Y
0.1-0.4 mg/dL
<0.1
>0.4
>1.0
>1.5
4Y-7Y
0.2-0.5 mg/dL
<0.2
>0.5
>1.0
>1.5
7Y-10Y
0.2-0.6 mg/dL
<0.2
>0.6
>1.0
>1.5
10Y-13Y
0.3-0.7 mg/dL
<0.3
>0.7
>1.2
>1.7
13Y-16Y
0.4-0.8 mg/dL
<0.4
>0.8
>1.5
>2.0
16Y-18Y
0.5-0.9 mg/dL
<0.5
>0.9
>2.0
>3.0
18Y-50Y
0.4-1.1 mg/dL
<0.4
>1.1
>2.0
>3.0
50Y-70Y
0.4-1.1 mg/dL
<0.4
>1.1
>2.0
>3.0
70Y-80Y
0.4-1.2 mg/dL
<0.4
>1.2
>2.0
>3.0
80Y-150Y 0.4-1.4 mg/dL
<0.4
>1.4
>2.0
>3.0
Male
0M-1M
0.2-0.9 mg/dL
<0.2
>0.9
>1.2
>1.5
1M-1Y
0.1-0.4 mg/dL
<0.1
>0.4
>1.0
>1.5
1Y-4Y
0.1-0.4 mg/dL
<0.1
>0.4
>1.0
>1.5
4Y-7Y
0.2-0.5 mg/dL
<0.2
>0.5
>1.0
>1.5
7Y-10Y
0.3-0.6 mg/dL
<0.3
>0.6
>1.0
>1.5
10Y-13Y
0.3-0.7 mg/dL
<0.3
>0.7
>1.2
>1.7
13Y-16Y
0.3-0.9 mg/dL
<0.3
>0.9
>1.5
>2.0
16Y-18Y
0.5-1.1 mg/dL
<0.5
>1.1
>2.0
>3.0
18Y-50Y
0.5-1.2 mg/dL
<0.5
>1.2
>2.0
>3.0
50Y-70Y
0.5-1.3 mg/dL
<0.5
>1.3
>2.0
>3.0
70Y-80Y
0.5-1.5 mg/dL
<0.5
>1.5
>2.0
>3.0
80Y-150Y 0.5-1.6 mg/dL
<0.5
>1.6
>2.0
>3.0
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
20-Oct-2006
Glucose (RCT11)
Both
0M-1M
55-115 mg/dL
<40
<45
<55
>115
>200
>250
1M-18Y
70-115 mg/dL
<40
<45
<70
>115
>300
>400
18Y-59Y
70-115 mg/dL
<40
<45
<70
>115
>300
>400
59Y-150Y 70-120 mg/dL
<40
<45
<70
>120
>300
>400
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
21-Mar-2002
Calcium (RCT183)
Both
Sodium (RCT15)
Both
0Y-2Y
9.0-11.0 mg/dL
<5.0
<7.0
<9.0
>11.0
>12.5
>14.0
2Y-18Y
8.4-10.3 mg/dL
<5.0
<7.0
<8.4
>10.3
>11.0
>13.0
18Y-150Y 8.3-10.6 mg/dL
<5.0
<7.0
<8.3
>10.6
>11.0
>13.0
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
29-Apr-1997
0Y-18Y
132-147 mEq/L
<115
<125
<132
>147
>155
>165
18Y-59Y
132-147 mEq/L
<115
<125
<132
>147
>155
>165
59Y-150Y 135-145 mEq/L
<115
<125
<135
>145
>155
>165
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
29-Apr-1997
Potassium (RCT16)
Both
0Y-1Y
3.7-5.6 mEq/L
<2.6
<3.0
<3.7
>5.6
>6.0
Page: 71
510013_TMEA_Printed: 20070606
>6.9
Run: 6-Jun-07
2:47 PM

Protocol: 2-001
Page:
4
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
29-Apr-1997
Continued...
Potassium (RCT16)
Both
1Y-18Y
3.4-5.4 mEq/L
<2.6
<3.0
<3.4
>5.4
>5.8
>6.9
18Y-59Y
3.4-5.4 mEq/L
<2.6
<3.0
<3.4
>5.4
>5.8
>6.9
59Y-150Y 3.4-5.4 mEq/L
<2.6
<3.0
<3.4
>5.4
>5.8
>6.9
__________________________________________________________________________________________________________________________________________________________
LT
L
H
HT
29-Mar-2000
Bicarb (RCT17)
Female
0Y-1Y
12.0-28.0 mEq/L
<12.0
>28.0
>32.0
1Y-4Y
12.0-28.0 mEq/L
<12.0
>28.0
>32.0
4Y-18Y
17.0-30.6 mEq/L
<15.1
<17.0
>30.6
>34.9
18Y-70Y
17.0-30.6 mEq/L
<15.1
<17.0
>30.6
>34.9
70Y-150Y 17.0-32.0 mEq/L
<15.1
<17.0
>32.0
>34.9
Male
0Y-1Y
12.0-28.0 mEq/L
<12.0
>28.0
>32.0
1Y-4Y
12.0-28.0 mEq/L
<12.0
>28.0
>32.0
4Y-18Y
17.0-30.6 mEq/L
<15.1
<17.0
>30.6
>34.9
18Y-70Y
17.0-30.6 mEq/L
<15.1
<17.0
>30.6
>34.9
70Y-150Y 17.0-32.0 mEq/L
<15.1
<17.0
>32.0
>34.9
__________________________________________________________________________________________________________________________________________________________
L
H
25-Apr-1997
Chloride (RCT18)
Both
Key:
Alert flags:
H
HP
HT
L
LP
LT
0Y-18Y
18Y-150Y
94-112 mEq/L
94-112 mEq/L
<94
<94
>112
>112
High
High Panic
High - Telephone
Low
Low Panic
Low - Telephone
Covance CLS
Page: 72
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:53 PM

Protocol: 2-001

Reported in: S.I. Units
Group: FIBRINOGEN
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
L
H
01-Mar-2007
Fibrinogen (CGT285)
Both
0Y-150Y
200-400 mg/dL
<200
>400
Key:
Alert flags:
H
L
High
Low
Covance CLS
Run: 6-Jun-07
2:53 PM

Protocol: 2-001

Group: INR
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
L
H
HT
28-Dec-2006
PT (CGT283)
Both
0Y-150Y
9.7-12.3 sec
<9.7
>12.3
>40.0
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
28-Dec-2006
INR (CGT286)
Key:
Alert flags:
Both
H
HP
HT
L
0Y-150Y
0.8-1.2
<0.8
>1.2
>3.0
>4.0
High
High Panic
High - Telephone
Low
Covance CLS
Page: 73
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:53 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
23-Oct-2000
HGB (HMT40)
Female
0Y-1D
135-220 g/L
<80
<100
<135
>220
1D-8D
135-220 g/L
<80
<100
<135
>220
8D-15D
125-210 g/L
<80
<100
<125
>210
15D-31D
100-200 g/L
<80
<100
>200
31D-4M
100-140 g/L
<80
<100
>140
4M-7M
100-140 g/L
<80
<100
>140
7M-2Y
105-135 g/L
<80
<105
>135
2Y-3Y
110-140 g/L
<80
<110
>140
3Y-6Y
118-147 g/L
<80
<118
>147
6Y-12Y
112-155 g/L
<60
<90
<112
>155
>190
>210
12Y-59Y
116-164 g/L
<60
<100
<116
>164
>190
>230
59Y-150Y 115-158 g/L
<60
<100
<115
>158
>190
>230
Male
0Y-1D
135-220 g/L
<80
<100
<135
>220
1D-8D
135-220 g/L
<80
<100
<135
>220
8D-15D
125-210 g/L
<80
<100
<125
>210
15D-31D
100-200 g/L
<80
<100
>200
31D-4M
100-140 g/L
<80
<100
>140
4M-7M
100-140 g/L
<80
<100
>140
7M-2Y
105-135 g/L
<80
<105
>135
2Y-3Y
110-140 g/L
<80
<110
>140
3Y-6Y
110-145 g/L
<80
<110
>145
6Y-12Y
112-155 g/L
<60
<80
<112
>155
>190
>210
12Y-59Y
127-181 g/L
<60
<100
<127
>181
>190
>230
59Y-150Y 125-170 g/L
<60
<100
<125
>170
>190
>230
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
16-Oct-2000
HCT (HMT2)
Run: 6-Jun-07
2:53 PM
Female
0Y-1D
0.42-0.60
<0.24
<0.30
<0.42
>0.60
>0.65
1D-8D
0.42-0.60
<0.24
<0.30
<0.42
>0.60
>0.65
8D-15D
0.39-0.60
<0.24
<0.30
<0.39
>0.60
>0.65
15D-31D
0.31-0.55
<0.20
<0.24
<0.31
>0.55
>0.60
31D-4M
0.28-0.42
<0.20
<0.24
<0.28
>0.42
>0.55
4M-7M
0.28-0.42
<0.20
<0.24
<0.28
>0.42
>0.55
7M-2Y
0.33-0.40
<0.20
<0.24
<0.33
>0.40
>0.50
2Y-3Y
0.33-0.42
<0.24
<0.28
<0.33
>0.42
>0.50
3Y-6Y
0.35-0.44
<0.28
<0.35
>0.44
>0.50
6Y-12Y
0.34-0.44
<0.28
<0.34
>0.44
>0.50
12Y-59Y
0.34-0.48
<0.28
<0.34
>0.48
>0.50
59Y-150Y 0.34-0.48
<0.28
<0.34
>0.48
>0.50
Male
0Y-1D
0.42-0.60
<0.24
<0.30
<0.42
>0.60
>0.65
1D-8D
0.42-0.60
<0.24
<0.30
<0.42
>0.60
>0.65
8D-15D
0.39-0.60
<0.24
<0.30
<0.39
>0.60
>0.65
15D-31D
0.31-0.55
<0.20
<0.24
<0.31
>0.55
>0.60
31D-4M
0.28-0.42
<0.20
<0.24
<0.28
>0.42
>0.55
4M-7M
0.28-0.42
<0.20
<0.24
<0.28
>0.42
>0.55
7M-2Y
0.33-0.40
<0.20
<0.24
<0.33
>0.40
>0.50
2Y-3Y
0.33-0.42
<0.24
<0.28
<0.33
>0.42
>0.50

Protocol: 2-001

Page:
2
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
16-Oct-2000
Continued...
HCT (HMT2)
Male
3Y-6Y
0.33-0.43
<0.24
<0.28
<0.33
>0.43
>0.50
6Y-12Y
0.34-0.44
<0.24
<0.34
>0.44
>0.50
12Y-59Y
0.39-0.54
<0.24
<0.39
>0.54
>0.55
59Y-150Y 0.37-0.51
<0.24
<0.37
>0.51
>0.55
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
16-Jan-2004
WBC (HMT7)
Female
0D-15D
8.30-17.60 GI/L
<1.00
<4.00
<8.30
>17.60
>30.00
>50.00
15D-31D
6.90-15.00 GI/L
<1.00
<3.00
<6.90
>15.00
>30.00
>50.00
31D-61D
6.10-13.80 GI/L
<1.00
<3.00
<6.10
>13.80
>25.00
>30.00
61D-7M
6.80-16.20 GI/L
<1.00
<3.00
<6.80
>16.20
>20.00
>30.00
7M-2Y
6.40-15.50 GI/L
<1.00
<3.00
<6.40
>15.50
>20.00
>30.00
2Y-6Y
5.50-12.50 GI/L
<1.00
<3.00
<5.50
>12.50
>15.00
>30.00
6Y-12Y
4.35-13.65 GI/L
<1.00
<2.00
<4.35
>13.65
>15.00
>30.00
12Y-18Y
4.35-13.15 GI/L
<1.00
<2.00
<4.35
>13.15
>15.00
>30.00
18Y-59Y
3.80-10.70 GI/L
<1.00
<2.50
<3.80
>10.70
>15.00
>30.00
59Y-150Y 3.80-10.70 GI/L
<1.00
<2.50
<3.80
>10.70
>15.00
>30.00
Male
0D-15D
8.60-14.90 GI/L
<1.00
<4.00
<8.60
>14.90
>30.00
>50.00
15D-31D
7.40-13.30 GI/L
<1.00
<3.00
<7.40
>13.30
>30.00
>50.00
31D-61D
6.00-13.70 GI/L
<1.00
<3.00
<6.00
>13.70
>25.00
>30.00
61D-7M
6.60-15.60 GI/L
<1.00
<3.00
<6.60
>15.60
>20.00
>30.00
7M-2Y
6.30-15.40 GI/L
<1.00
<3.00
<6.30
>15.40
>20.00
>30.00
2Y-6Y
5.50-12.30 GI/L
<1.00
<3.00
<5.50
>12.30
>15.00
>30.00
6Y-12Y
4.35-13.65 GI/L
<1.00
<2.00
<4.35
>13.65
>15.00
>30.00
12Y-18Y
4.35-13.15 GI/L
<1.00
<2.00
<4.35
>13.15
>15.00
>30.00
18Y-59Y
3.80-10.70 GI/L
<1.00
<2.50
<3.80
>10.70
>15.00
>30.00
59Y-150Y 3.80-10.70 GI/L
<1.00
<2.50
<3.80
>10.70
>15.00
>30.00
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
26-Dec-2000
Neutrophil (HMT8)
Female
0D-1D
6.00-26.00 GI/L
<1.00
<6.00
>26.00
>40.00
1D-8D
2.00-21.00 GI/L
<1.00
<2.00
>21.00
>40.00
8D-15D
1.00-10.00 GI/L
<0.50
<1.00
>10.00
>40.00
15D-31D
1.00-9.50 GI/L
<0.50
<1.00
>9.50
>11.00
31D-4M
1.00-9.00 GI/L
<0.50
<1.00
>9.00
>11.00
4M-7M
1.00-9.00 GI/L
<0.50
<1.00
>9.00
>11.00
7M-2Y
1.50-9.60 GI/L
<0.50
<1.00
<1.50
>9.60
>12.00
2Y-3Y
1.00-9.00 GI/L
<0.50
<1.00
>9.00
>11.00
3Y-6Y
1.00-9.00 GI/L
<0.50
<1.00
>9.00
>11.00
6Y-12Y
1.35-8.15 GI/L
<0.50
<1.00
<1.35
>8.15
>11.00
12Y-18Y
1.65-8.15 GI/L
<0.50
<1.00
<1.65
>8.15
>11.00
18Y-59Y
1.96-7.23 GI/L
<0.50
<1.00
<1.96
>7.23
>11.00
59Y-150Y 1.96-7.23 GI/L
<0.50
<1.00
<1.96
>7.23
>11.00
Male
0D-1D
6.00-26.00 GI/L
<1.00
<6.00
>26.00
>40.00
1D-8D
2.00-21.00 GI/L
<1.00
<2.00
>21.00
>40.00
8D-15D
1.00-10.00 GI/L
<0.50
<1.00
>10.00
>40.00
Page: 74
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:53 PM

Protocol: 2-001

Page:
3
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
26-Dec-2000
Continued...
Neutrophil (HMT8)
Male
15D-31D
1.00-9.50 GI/L
<0.50
<1.00
>9.50
>11.00
31D-4M
1.00-9.00 GI/L
<0.50
<1.00
>9.00
>11.00
4M-7M
1.00-9.00 GI/L
<0.50
<1.00
>9.00
>11.00
7M-2Y
1.50-9.40 GI/L
<0.50
<1.00
<1.50
>9.40
>12.00
2Y-3Y
1.35-8.65 GI/L
<0.50
<1.00
<1.35
>8.65
>11.00
3Y-6Y
1.35-8.65 GI/L
<0.50
<1.00
<1.35
>8.65
>11.00
6Y-12Y
1.35-8.15 GI/L
<0.50
<1.00
<1.35
>8.15
>11.00
12Y-18Y
1.65-8.15 GI/L
<0.50
<1.00
<1.65
>8.15
>11.00
18Y-59Y
1.96-7.23 GI/L
<0.50
<1.00
<1.96
>7.23
>11.00
59Y-150Y 1.96-7.23 GI/L
<0.50
<1.00
<1.96
>7.23
>11.00
__________________________________________________________________________________________________________________________________________________________
H
29-Sep-1993
Bands (HMT20)
Both
0Y-150Y
0.00-0.27 GI/L
>0.27
__________________________________________________________________________________________________________________________________________________________
LT
L
H
HT
26-Dec-2000
Lymphocyte (HMT9)
Female
Male
Covance CLS
Run: 6-Jun-07
2:53 PM
0D-1D
1D-8D
8D-15D
15D-31D
31D-4M
4M-7M
7M-2Y
2Y-3Y
3Y-6Y
6Y-12Y
12Y-18Y
18Y-59Y
59Y-150Y
0D-1D
1D-8D
8D-15D
15D-31D
31D-4M
4M-7M
7M-2Y
2Y-3Y
3Y-6Y
6Y-12Y
12Y-18Y
18Y-59Y
59Y-150Y
2.00-11.00 GI/L
2.00-17.00 GI/L
2.00-17.00 GI/L
2.50-17.00 GI/L
2.50-16.00 GI/L
3.00-15.00 GI/L
1.70-6.70 GI/L
1.50-10.00 GI/L
1.50-8.00 GI/L
1.15-6.65 GI/L
0.95-5.25 GI/L
0.91-4.28 GI/L
0.80-3.00 GI/L
2.00-11.00 GI/L
2.00-17.00 GI/L
2.00-17.00 GI/L
2.50-17.00 GI/L
2.50-16.00 GI/L
3.00-15.00 GI/L
1.70-6.50 GI/L
1.50-10.00 GI/L
1.50-8.00 GI/L
1.15-6.65 GI/L
0.95-5.25 GI/L
0.91-4.28 GI/L
0.80-3.00 GI/L
<0.50
<0.50
<0.50
<0.50
<0.50
<0.50
<1.30
<1.00
<1.00
<0.50
<0.50
<0.50
<0.50
<0.50
<0.50
<1.30
<1.00
<1.00
<2.00
<2.00
<2.00
<2.50
<2.50
<3.00
<1.70
<1.50
<1.50
<1.15
<0.95
<0.91
<0.80
<2.00
<2.00
<2.00
<2.50
<2.50
<3.00
<1.70
<1.50
<1.50
<1.15
<0.95
<0.91
<0.80
>11.00
>17.00
>17.00
>17.00
>16.00
>15.00
>6.70
>10.00
>8.00
>6.65
>5.25
>4.28
>3.00
>11.00
>17.00
>17.00
>17.00
>16.00
>15.00
>6.50
>10.00
>8.00
>6.65
>5.25
>4.28
>3.00
>25.00
>25.00
>25.00
>25.00
>25.00
>25.00
>10.00
>25.00
>25.00
>25.00
>25.00
>25.00
>25.00
>25.00
>25.00
>10.00
>25.00
>25.00

Protocol: 2-001

Page:
4
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
L
H
13-Jul-2006
Monocytes (HMT10)
Female
0D-4D
0.20-2.20 GI/L
<0.20
>2.20
4D-8D
0.20-2.20 GI/L
<0.20
>2.20
8D-15D
0.10-2.90 GI/L
<0.10
>2.90
15D-31D
0.20-5.00 GI/L
<0.20
>5.00
31D-61D
0.20-2.10 GI/L
<0.20
>2.10
61D-180D 0.60-1.90 GI/L
<0.60
>1.90
180D-2Y
0.30-1.50 GI/L
<0.30
>1.50
2Y-6Y
0.50-1.10 GI/L
<0.50
>1.10
6Y-12Y
0.40-0.90 GI/L
<0.40
>0.90
12Y-18Y
0.40-0.90 GI/L
<0.40
>0.90
18Y-150Y 0.12-0.92 GI/L
<0.12
>0.92
Male
0D-4D
0.20-1.80 GI/L
<0.20
>1.80
4D-8D
0.20-2.20 GI/L
<0.20
>2.20
8D-15D
0.30-3.00 GI/L
<0.30
>3.00
15D-31D
0.20-3.50 GI/L
<0.20
>3.50
31D-61D
0.30-2.70 GI/L
<0.30
>2.70
61D-180D 0.50-1.90 GI/L
<0.50
>1.90
180D-2Y
0.40-2.00 GI/L
<0.40
>2.00
2Y-6Y
0.30-1.20 GI/L
<0.30
>1.20
6Y-12Y
0.30-0.90 GI/L
<0.30
>0.90
12Y-18Y
0.40-1.30 GI/L
<0.40
>1.30
18Y-150Y 0.12-0.92 GI/L
<0.12
>0.92
__________________________________________________________________________________________________________________________________________________________
H
13-Jul-2006
Eosinophil (HMT11)
Female
0D-4D
0.00-0.20 GI/L
>0.20
4D-8D
0.00-0.50 GI/L
>0.50
8D-15D
0.00-0.60 GI/L
>0.60
15D-31D
0.00-0.50 GI/L
>0.50
31D-61D
0.00-0.20 GI/L
>0.20
61D-180D 0.00-0.10 GI/L
>0.10
180D-2Y
0.00-0.20 GI/L
>0.20
2Y-6Y
0.00-0.20 GI/L
>0.20
6Y-12Y
0.00-0.20 GI/L
>0.20
12Y-18Y
0.00-0.20 GI/L
>0.20
18Y-150Y 0.00-0.57 GI/L
>0.57
Male
0D-4D
0.00-0.30 GI/L
>0.30
4D-8D
0.00-0.80 GI/L
>0.80
8D-15D
0.00-0.60 GI/L
>0.60
15D-31D
0.00-0.90 GI/L
>0.90
31D-61D
0.00-0.50 GI/L
>0.50
61D-180D 0.00-0.40 GI/L
>0.40
180D-2Y
0.00-0.30 GI/L
>0.30
2Y-6Y
0.00-0.20 GI/L
>0.20
6Y-12Y
0.00-0.30 GI/L
>0.30
12Y-18Y
0.00-0.30 GI/L
>0.30
18Y-150Y 0.00-0.57 GI/L
>0.57
Page: 75
510013_TMEA_Printed: 20070606
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2:53 PM

Protocol: 2-001

Page:
5
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
29-Sep-1993
Basophils (HMT12)
Both
0Y-150Y
0.00-0.20 GI/L
>0.20
__________________________________________________________________________________________________________________________________________________________
L
H
09-Sep-1993
Neutrophil (HMT15)
Both
0Y-150Y
40.5-75.0 %
<40.5
>75.0
__________________________________________________________________________________________________________________________________________________________
H
18-Aug-1993
Bands (HMT21)
Both
0Y-150Y
0.0-3.0 %
>3.0
__________________________________________________________________________________________________________________________________________________________
L
H
02-Jun-1993
Lymphocyte (HMT16)
Both
0Y-150Y
15.4-48.5%
<15.4
>48.5
__________________________________________________________________________________________________________________________________________________________
L
H
13-Jul-2006
Monocytes (HMT17)
Female
0D-4D
5.0-11.0 %
<5.0
>11.0
4D-8D
6.0-14.0 %
<6.0
>14.0
8D-15D
6.0-19.0 %
<6.0
>19.0
15D-31D
5.0-14.0 %
<5.0
>14.0
31D-61D
5.0-14.0 %
<5.0
>14.0
61D-180D 4.0-12.0 %
<4.0
>12.0
180D-2Y
4.0-9.0 %
<4.0
>9.0
2Y-6Y
4.0-8.0 %
<4.0
>8.0
6Y-12Y
4.0-7.0 %
<4.0
>7.0
12Y-18Y
4.0-7.0 %
<4.0
>7.0
18Y-150Y 2.6-10.1 %
<2.6
>10.1
Male
0D-4D
4.0-13.0 %
<4.0
>13.0
4D-8D
7.0-17.0 %
<7.0
>17.0
8D-15D
7.0-18.0 %
<7.0
>18.0
15D-31D
6.0-18.0 %
<6.0
>18.0
31D-61D
6.0-17.0 %
<6.0
>17.0
61D-180D 4.0-11.0 %
<4.0
>11.0
180D-2Y
1.0-10.0 %
<1.0
>10.0
2Y-6Y
4.0-9.0 %
<4.0
>9.0
6Y-12Y
4.0-8.0 %
<4.0
>8.0
12Y-18Y
4.0-8.0 %
<4.0
>8.0
18Y-150Y 2.6-10.1 %
<2.6
>10.1
__________________________________________________________________________________________________________________________________________________________
H
13-Jul-2006
Eosinophil (HMT18)
Female
Covance CLS
Run: 6-Jun-07
2:53 PM
0D-4D
0.0-3.9 %
>3.9
4D-8D
0.0-7.5 %
>7.5
8D-15D
0.0-4.1 %
>4.1
15D-31D
0.0-5.4 %
>5.4
31D-61D
0.0-3.1 %
>3.1
61D-180D 0.0-2.8 %
>2.8

Protocol: 2-001

Page:
6
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
13-Jul-2006
Continued...
Eosinophil (HMT18)
Female
180D-2Y
0.0-3.1 %
>3.1
2Y-6Y
0.0-3.3 %
>3.3
6Y-12Y
0.0-4.0 %
>4.0
12Y-18Y
0.0-4.1 %
>4.1
18Y-150Y 0.0-6.8 %
>6.8
Male
0D-4D
0.0-2.9 %
>2.9
4D-8D
0.0-5.4 %
>5.4
8D-15D
0.0-5.0 %
>5.0
15D-31D
0.0-7.0 %
>7.0
31D-61D
0.0-5.4 %
>5.4
61D-180D 0.0-3.5 %
>3.5
180D-2Y
0.0-2.0 %
>2.0
2Y-6Y
0.0-2.4 %
>2.4
6Y-12Y
0.0-4.8 %
>4.8
12Y-18Y
0.0-2.8 %
>2.8
18Y-150Y 0.0-6.8 %
>6.8
__________________________________________________________________________________________________________________________________________________________
H
13-Jul-2006
Basophils (HMT19)
0D-4D
0.0-1.0 %
>1.0
4D-8D
0.0-1.0 %
>1.0
8D-15D
0.0-1.0 %
>1.0
15D-31D
0.0-1.0 %
>1.0
31D-61D
0.0-1.0 %
>1.0
61D-180D 0.0-1.0 %
>1.0
180D-2Y
0.0-1.0 %
>1.0
2Y-6Y
0.0-1.0 %
>1.0
6Y-12Y
0.0-1.0 %
>1.0
12Y-18Y
0.0-1.0 %
>1.0
18Y-150Y 0.0-2.0 %
>2.0
Male
0D-4D
0.0-1.0 %
>1.0
4D-8D
0.0-1.0 %
>1.0
8D-15D
0.0-1.0 %
>1.0
15D-31D
0.0-1.0 %
>1.0
31D-61D
0.0-1.0 %
>1.0
61D-180D 0.0-1.0 %
>1.0
180D-2Y
0.0-1.0 %
>1.0
2Y-6Y
0.0-1.0 %
>1.0
6Y-12Y
0.0-1.0 %
>1.0
12Y-18Y
0.0-1.0 %
>1.0
18Y-150Y 0.0-2.0 %
>2.0
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
26-Apr-1995
Platelets (HMT13)
Female
Female
Covance CLS
0D-1D
200-400 GI/L
<100
<110
<200
>400
>600
1D-8D
200-400 GI/L
<100
<110
<200
>400
>600
Page: 76
510013_TMEA_Printed: 20070606
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2:53 PM

Protocol: 2-001

Page:
7
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
26-Apr-1995
Continued...
Platelets (HMT13)
Female
8D-15D
200-400 GI/L
<100
<110
<200
>400
>600
15D-31D
200-400 GI/L
<100
<110
<200
>400
>600
31D-4M
200-400 GI/L
<100
<110
<200
>400
>600
4M-7M
200-400 GI/L
<100
<110
<200
>400
>600
7M-2Y
200-400 GI/L
<100
<110
<200
>400
>600
2Y-3Y
252-582 GI/L
<100
<110
<252
>582
>600
3Y-6Y
240-570 GI/L
<100
<110
<240
>570
>600
6Y-12Y
130-394 GI/L
<100
<110
<130
>394
>600
12Y-60Y
140-400 GI/L
<100
<110
<140
>400
>600
60Y-150Y 130-394 GI/L
<100
<110
<130
>394
>600
Male
0D-1D
200-400 GI/L
<100
<110
<200
>400
>600
1D-8D
200-400 GI/L
<100
<110
<200
>400
>600
8D-15D
200-400 GI/L
<100
<110
<200
>400
>600
15D-31D
200-400 GI/L
<100
<110
<200
>400
>600
31D-4M
200-400 GI/L
<100
<110
<200
>400
>600
4M-7M
200-400 GI/L
<100
<110
<200
>400
>600
7M-2Y
200-400 GI/L
<100
<110
<200
>400
>600
2Y-3Y
252-582 GI/L
<100
<110
<252
>582
>600
3Y-6Y
240-570 GI/L
<100
<110
<240
>570
>600
6Y-12Y
130-394 GI/L
<100
<110
<130
>394
>600
12Y-60Y
140-400 GI/L
<100
<110
<140
>400
>600
60Y-150Y 130-394 GI/L
<100
<110
<130
>394
>600
Key:
Alert flags:
H
HP
HT
L
LP
LT
High
High Panic
High - Telephone
Low
Low Panic
Low - Telephone
Covance CLS
Run: 6-Jun-07
2:53 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Blasts (HMT97)
Both
0Y-150Y
0%
>0
Key:
Alert flags:
HT
High - Telephone
Covance CLS
Page: 77
510013_TMEA_Printed: 20070606
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2:53 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Metamyelo (HMT69)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Myelocyte (HMT68)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Promyelocy (HMT67)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Myeloblast (HMT66)
Key:
Alert flags:
Both
H
HT
0Y-150Y
0%
>0
High
High - Telephone
Covance CLS
Run: 6-Jun-07
2:53 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Prolymph (HMT56)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Ly,Immunob (HMT59)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Ly,Plasmcy (HMT60)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Lymph,Reac (HMT61)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Lymphoblas (HMT62)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Atyp Lymph (HMT96)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Lymphoma C (HMT55)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Sezary, % (HMT57)
Key:
Alert flags:
Both
H
HT
0Y-150Y
0%
>0
High
High - Telephone
Covance CLS
Page: 78
510013_TMEA_Printed: 20070606
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2:53 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Promonocyt (HMT63)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Mono,Immat (HMT65)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Monoblast (HMT64)
Key:
Alert flags:
Both
H
HT
0Y-150Y
0%
>0
High
High - Telephone
Covance CLS
Run: 6-Jun-07
2:53 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
14-Feb-1997
Eos,Immat (HMT49)
Both
0Y-150Y
0%
>0
Key:
Alert flags:
High
Covance CLS
Page: 79
510013_TMEA_Printed: 20070606
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2:53 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
18-Jul-1994
Baso,Immat (HMT48)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Plasma Pre (HMT52)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
14-Feb-1997
Plasma Imm (HMT53)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Plasma Cel (HMT54)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Malign,Nos (HMT50)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Hairy Cell (HMT58)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
NRBC (HMT70)
Both
0Y-150Y
0%
>0
__________________________________________________________________________________________________________________________________________________________
18-Sep-1992
CBC Commt: (HMT51)
Both
0Y-150Y
Key:
Alert flags:
H
HT
High
High - Telephone
Covance CLS
Run: 6-Jun-07
2:54 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Blasts (HMT94)
Both
0Y-150Y
0 GI/L
>0.00
Key:
Alert flags:
HT
High - Telephone
Covance CLS
Page: 80
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:54 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Metamyelo (HMT93)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Myelocyte (HMT92)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Promyelocy (HMT91)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Myeloblast (HMT90)
Key:
Alert flags:
Both
H
HT
0Y-150Y
0 GI/L
>0.00
High
High - Telephone
Covance CLS
Run: 6-Jun-07
2:54 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Prolymph (HMT81)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Ly,Immunob (HMT83)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Ly,Plasmcy (HMT84)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Lymph,Reac (HMT85)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Lymphoblas (HMT86)
Both
0Y-150Y
0 GI/L
>0.00
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Atyp Lymph (HMT95)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Lymphoma C (HMT80)
Both
0Y-150Y
0 GI/L
>0.00
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Sezary,Abs (HMT72)
Key:
Alert flags:
Both
H
HT
0Y-150Y
0 GI/L
>0
High
High - Telephone
Covance CLS
Page: 81
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:54 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Promonocyt (HMT87)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Mono,Immat (HMT89)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Monoblast (HMT88)
Key:
Alert flags:
Both
H
HT
0Y-150Y
0 GI/L
>0.00
High
High - Telephone
Covance CLS
Run: 6-Jun-07
2:54 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Eos,Immat (HMT75)
Both
0Y-150Y
GI/L
>0
0
Key:
Alert flags:
High
Covance CLS
Page: 82
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:54 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Baso,Immat (HMT74)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Plasma Pre (HMT77)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Plasma Imm (HMT78)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Plasma Cel (HMT79)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
Malign,NOS (HMT76)
Both
0Y-150Y
0 GI/L
>0
__________________________________________________________________________________________________________________________________________________________
HT
19-Jul-1994
Hairy Cell (HMT82)
Both
0Y-150Y
0 GI/L
>0.00
__________________________________________________________________________________________________________________________________________________________
H
19-Jul-1994
NRBC (HMT98)
Both
0Y-150Y
0%
>0.00
__________________________________________________________________________________________________________________________________________________________
09-Dec-1992
CBC Commt: (HMT99)
Both
0Y-150Y
Key:
Alert flags:
H
HT
High
High - Telephone
Covance CLS
Run: 6-Jun-07
2:54 PM

Protocol: 2-001

Group: HEMATOLOGY II
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
26-Apr-1995
Platelets (HMT13)
Female
0D-1D
200-400 GI/L
<100
<110
<200
>400
>600
1D-8D
200-400 GI/L
<100
<110
<200
>400
>600
8D-15D
200-400 GI/L
<100
<110
<200
>400
>600
15D-31D
200-400 GI/L
<100
<110
<200
>400
>600
31D-4M
200-400 GI/L
<100
<110
<200
>400
>600
4M-7M
200-400 GI/L
<100
<110
<200
>400
>600
7M-2Y
200-400 GI/L
<100
<110
<200
>400
>600
2Y-3Y
252-582 GI/L
<100
<110
<252
>582
>600
3Y-6Y
240-570 GI/L
<100
<110
<240
>570
>600
6Y-12Y
130-394 GI/L
<100
<110
<130
>394
>600
12Y-60Y
140-400 GI/L
<100
<110
<140
>400
>600
60Y-150Y 130-394 GI/L
<100
<110
<130
>394
>600
Male
0D-1D
200-400 GI/L
<100
<110
<200
>400
>600
1D-8D
200-400 GI/L
<100
<110
<200
>400
>600
8D-15D
200-400 GI/L
<100
<110
<200
>400
>600
15D-31D
200-400 GI/L
<100
<110
<200
>400
>600
31D-4M
200-400 GI/L
<100
<110
<200
>400
>600
4M-7M
200-400 GI/L
<100
<110
<200
>400
>600
7M-2Y
200-400 GI/L
<100
<110
<200
>400
>600
2Y-3Y
252-582 GI/L
<100
<110
<252
>582
>600
3Y-6Y
240-570 GI/L
<100
<110
<240
>570
>600
6Y-12Y
130-394 GI/L
<100
<110
<130
>394
>600
12Y-60Y
140-400 GI/L
<100
<110
<140
>400
>600
60Y-150Y 130-394 GI/L
<100
<110
<130
>394
>600
Key:
Alert flags:
H
HT
L
LP
LT
High
High - Telephone
Low
Low Panic
Low - Telephone
Covance CLS
Page: 83
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:54 PM

Protocol: 2-001

Group: D-DIMER
Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
HT
20-Apr-2007
D-Dimer (IMT1209)
Both
0Y-18Y
ng/mL(FEU)
No Ref Rng
18Y-150Y <500 ng/mL(FEU)
>499.999999
Key:
Alert flags:
HT
High - Telephone
Covance CLS
Run: 6-Jun-07
2:54 PM

Protocol: 2-001

Page:
1
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
22-Mar-2001
Total Bili (RCT1)
Both
0W-2W
3-200 umol/L
<3
>200
>342
2W-18Y
3-21 umol/L
<3
>21
>34
>51
18Y-150Y 3-21 umol/L
<3
>21
>34
>51
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
24-Jan-2003
Alk Phos (RCT1407)
Female
0M-1M
48-406 U/L
<48
>406
>500
>750
1M-1Y
124-341 U/L
<124
>341
>500
>750
1Y-4Y
108-317 U/L
<108
>317
>500
>750
4Y-7Y
96-297 U/L
<96
>297
>500
>750
7Y-10Y
69-325 U/L
<69
>325
>500
>750
10Y-15Y
51-300 U/L
<51
>300
>400
>750
15Y-18Y
31-110 U/L
<31
>110
>200
>500
18Y-50Y
31-106 U/L
<31
>106
>200
>500
50Y-60Y
35-123 U/L
<35
>123
>300
>500
60Y-70Y
35-123 U/L
<35
>123
>300
>500
70Y-80Y
35-135 U/L
<35
>135
>300
>500
80Y-90Y
35-135 U/L
<35
>135
>300
>500
90Y-150Y 35-140 U/L
<35
>140
>300
>500
Male
0M-1M
75-316 U/L
<75
>316
>500
>750
1M-1Y
82-383 U/L
<82
>383
>500
>750
1Y-4Y
104-345 U/L
<104
>345
>500
>750
4Y-7Y
93-309 U/L
<93
>309
>500
>750
7Y-10Y
86-315 U/L
<86
>315
>500
>750
10Y-15Y
95-385 U/L
<95
>385
>500
>750
15Y-18Y
50-250 U/L
<50
>250
>300
>750
18Y-50Y
31-129 U/L
<31
>129
>250
>500
50Y-60Y
35-131 U/L
<35
>131
>300
>500
60Y-70Y
35-125 U/L
<35
>125
>300
>500
70Y-80Y
35-130 U/L
<35
>130
>300
>500
80Y-90Y
35-125 U/L
<35
>125
>300
>500
90Y-150Y 35-125 U/L
<35
>125
>300
>500
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
23-Nov-2004
ALT (SGPT) (RCT4)
Female
0Y-1Y
<=54 U/L
1Y-4Y
6-34 U/L
4Y-7Y
6-34 U/L
7Y-10Y
6-34 U/L
10Y-18Y
6-34 U/L
18Y-69Y
6-34 U/L
69Y-150Y 6-32 U/L
Male
0Y-1Y
<=54 U/L
1Y-4Y
6-34 U/L
4Y-7Y
6-34 U/L
7Y-10Y
6-34 U/L
10Y-18Y
6-43 U/L
>54
>100
>200
>34
>100
>200
>34
>100
>200
>34
>100
>200
>34
>200
>300
>34
>200
>300
>32
>200
>300
>54
>100
>200
<6
>34
>100
>200
<6
>34
>100
>200
<6
>34
>100
>200
<6
>43
>200
>300
46214-2985 (317) 271-1200 FAX (317) 616-2351
<6
<6
<6
<6
<6
<6
Page: 84
510013_TMEA_Printed: 20070606
Run: 6-Jun-07
2:54 PM

Protocol: 2-001

Page:
2
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
23-Nov-2004
Continued...
ALT (SGPT) (RCT4)
Male
18Y-69Y
6-43 U/L
<6
>43
>200
>300
69Y-150Y 6-35 U/L
<6
>35
>200
>300
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
27-Dec-2000
AST (SGOT) (RCT5)
Female
0Y-1Y
10-80 U/L
<10
>80
>200
>300
1Y-4Y
10-56 U/L
<10
>56
>100
>200
4Y-7Y
10-48 U/L
<10
>48
>100
>200
7Y-18Y
10-40 U/L
<10
>40
>100
>200
18Y-59Y
9-34 U/L
<9
>34
>200
>300
59Y-150Y 9-34 U/L
<9
>34
>200
>300
Male
0Y-1Y
10-80 U/L
<10
>80
>200
>300
1Y-4Y
10-69 U/L
<10
>69
>100
>200
4Y-7Y
10-59 U/L
<10
>59
>100
>200
7Y-18Y
10-40 U/L
<10
>40
>100
>200
18Y-59Y
11-36 U/L
<11
>36
>200
>300
59Y-150Y 11-36 U/L
<11
>36
>200
>300
__________________________________________________________________________________________________________________________________________________________
L
H
HP
24-Jan-2003
LDH (RCT1408)
Female
Urea Nitr (RCT6)
Both
0M-1M
145-765 U/L
<145
>765
>1000
1M-1Y
190-420 U/L
<190
>420
>1000
1Y-3Y
165-395 U/L
<165
>395
>500
3Y-6Y
135-345 U/L
<135
>345
>500
6Y-9Y
140-280 U/L
<140
>280
>500
9Y-12Y
120-260 U/L
<120
>260
>500
12Y-15Y
100-275 U/L
<100
>275
>500
15Y-18Y
105-230 U/L
<105
>230
>500
18Y-150Y 53-234 U/L
<53
>234
>350
Male
0M-1M
125-735 U/L
<125
>735
>1000
1M-1Y
170-450 U/L
<170
>450
>1000
1Y-3Y
155-345 U/L
<155
>345
>500
3Y-6Y
155-345 U/L
<155
>345
>500
6Y-9Y
145-300 U/L
<145
>300
>500
9Y-12Y
120-325 U/L
<120
>325
>500
12Y-15Y
120-290 U/L
<120
>290
>500
15Y-18Y
105-235 U/L
<105
>235
>500
18Y-150Y 53-234 U/L
<53
>234
>350
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
25-Jun-2005
Covance CLS
Run: 6-Jun-07
2:54 PM
0Y-18Y
18Y-70Y
70Y-80Y
80Y-150Y
1.4-8.6 mmol/L
1.4-8.6 mmol/L
1.4-10.4 mmol/L
1.4-12.1 mmol/L
<1.4
<1.4
<1.4
<1.4
>8.6
>8.6
>10.4
>12.1
>12.5
>12.5
>14.3
>14.3
>17.9
>17.9
>17.9
>17.9

Protocol: 2-001

Page:
3
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
L
H
HT
HP
24-Aug-2000
Creatinine (RCT392)
Female
0M-1M
14-57 umol/L
<14
>57
>92
>137
1M-1Y
5-30 umol/L
<5
>30
>92
>137
1Y-4Y
5-39 umol/L
<5
>39
>92
>137
4Y-7Y
14-48 umol/L
<14
>48
>92
>137
7Y-10Y
14-57 umol/L
<14
>57
>92
>137
10Y-13Y
23-66 umol/L
<23
>66
>110
>154
13Y-16Y
31-75 umol/L
<31
>75
>137
>181
16Y-18Y
40-83 umol/L
<40
>83
>181
>269
18Y-50Y
31-101 umol/L
<31
>101
>181
>269
50Y-70Y
31-101 umol/L
<31
>101
>181
>269
70Y-80Y
31-110 umol/L
<31
>110
>181
>269
80Y-150Y 31-128 umol/L
<31
>128
>181
>269
Male
0M-1M
14-83 umol/L
<14
>83
>110
>137
1M-1Y
5-39 umol/L
<5
>39
>92
>137
1Y-4Y
5-39 umol/L
<5
>39
>92
>137
4Y-7Y
14-48 umol/L
<14
>48
>92
>137
7Y-10Y
23-57 umol/L
<23
>57
>92
>137
10Y-13Y
23-66 umol/L
<23
>66
>110
>154
13Y-16Y
23-83 umol/L
<23
>83
>137
>181
16Y-18Y
40-101 umol/L
<40
>101
>181
>269
18Y-50Y
40-110 umol/L
<40
>110
>181
>269
50Y-70Y
40-119 umol/L
<40
>119
>181
>269
70Y-80Y
40-137 umol/L
<40
>137
>181
>269
80Y-150Y 40-145 umol/L
<40
>145
>181
>269
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
20-Oct-2006
Glucose (RCT11)
Both
0M-1M
3.1-6.4 mmol/L
<2.2
<2.5
<3.1
>6.4
>11.1
>13.9
1M-18Y
3.9-6.4 mmol/L
<2.2
<2.5
<3.9
>6.4
>16.7
>22.2
18Y-59Y
3.9-6.4 mmol/L
<2.2
<2.5
<3.9
>6.4
>16.7
>22.2
59Y-150Y 3.9-6.7 mmol/L
<2.2
<2.5
<3.9
>6.7
>16.7
>22.2
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
21-Mar-2002
Calcium (RCT183)
Both
Sodium (RCT15)
Both
0Y-2Y
2.25-2.74 mmol/L
<1.25
<1.75
<2.25
>2.74
>3.12
>3.49
2Y-18Y
2.10-2.57 mmol/L
<1.25
<1.75
<2.10
>2.57
>2.74
>3.24
18Y-150Y 2.07-2.64 mmol/L
<1.25
<1.75
<2.07
>2.64
>2.74
>3.24
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
29-Apr-1997
0Y-18Y
132-147 mmol/L
<115
<125
<132
>147
>155
>165
18Y-59Y
132-147 mmol/L
<115
<125
<132
>147
>155
>165
59Y-150Y 135-145 mmol/L
<115
<125
<135
>145
>155
>165
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
29-Apr-1997
Potassium (RCT16)
Both
0Y-1Y
3.7-5.6 mmol/L
<2.6
<3.0
<3.7
>5.6
>6.0
Page: 85
510013_TMEA_Printed: 20070606
>6.9
Run: 6-Jun-07
2:54 PM

Protocol: 2-001

Page:
4
Project: 510013
Test
Ethnic
Sex
Age
Range
A l e r t
F l a g s
Effective Date
__________________________________________________________________________________________________________________________________________________________
LP
LT
L
H
HT
HP
29-Apr-1997
Continued...
Potassium (RCT16)
Both
1Y-18Y
3.4-5.4 mmol/L
<2.6
<3.0
<3.4
>5.4
>5.8
>6.9
18Y-59Y
3.4-5.4 mmol/L
<2.6
<3.0
<3.4
>5.4
>5.8
>6.9
59Y-150Y 3.4-5.4 mmol/L
<2.6
<3.0
<3.4
>5.4
>5.8
>6.9
__________________________________________________________________________________________________________________________________________________________
LT
L
H
HT
29-Mar-2000
Bicarb (RCT17)
Female
0Y-1Y
12.0-28.0 mmol/L
<12.0
>28.0
>32.0
1Y-4Y
12.0-28.0 mmol/L
<12.0
>28.0
>32.0
4Y-18Y
17.0-30.6 mmol/L
<15.1
<17.0
>30.6
>34.9
18Y-70Y
17.0-30.6 mmol/L
<15.1
<17.0
>30.6
>34.9
70Y-150Y 17.0-32.0 mmol/L
<15.1
<17.0
>32.0
>34.9
Male
0Y-1Y
12.0-28.0 mmol/L
<12.0
>28.0
>32.0
1Y-4Y
12.0-28.0 mmol/L
<12.0
>28.0
>32.0
4Y-18Y
17.0-30.6 mmol/L
<15.1
<17.0
>30.6
>34.9
18Y-70Y
17.0-30.6 mmol/L
<15.1
<17.0
>30.6
>34.9
70Y-150Y 17.0-32.0 mmol/L
<15.1
<17.0
>32.0
>34.9
__________________________________________________________________________________________________________________________________________________________
L
H
25-Apr-1997
Chloride (RCT18)
Both
Key:
Alert flags:
H
HP
HT
L
LP
LT
0Y-18Y
18Y-150Y
94-112 mmol/L
94-112 mmol/L
<94
<94
>112
>112
High
High Panic
High - Telephone
Low
Low Panic
Low - Telephone
Covance CLS
Page: 86
510013_TMEA_Printed: 20070606
Page: 87
510013_TMEA_Printed: 20070606
CONTACT NUMBERS TO CALL COVANCE CLS
To call Covance CLS in Indianapolis from:

Japan
1-317-271-1200
US, Canada, Puerto Rico
800-327-7270 (Toll Free)

317-271-1200 (Local calls)
317-616-2362 (Fax)
Latin America
317-271-1200 ext. 7205 or 7234 (Collect call)

317-616-2366 (Fax)
Argentina (ALA)
0800-288-5288 (Toll Free)
Argentina (Telecom)
0800-555-4288 (Toll Free)
Argentina (Telefonica)
0800-222-1288 (Toll Free)
Brazil
0800-891-2507 (Direct)
or 0800-890-0288 (Toll Free)
or 0800-8888-288 (Toll Free)
plus 800-476-7136
Chile (Entel)
800-225-288 (Toll Free)
plus 800-476-7136
Chile (CTC Mundo)
1230-020-0078 (Direct)
or 800-225-288 (Toll Free)
plus 800-476-7136
01-800-912-0075 (Direct)
or 01-800-911-0010 (Toll Free)
plus 800-476-7136
0-800-011-0870 (Direct)
or 0-800-0-114-114 (Toll Free)
plus 800-476-7136
Colombia
Costa Rica
Dominican Republic
1-800-872-2881 (Toll Free)
Ecuador (Andinatel)
999-119 (Toll Free)
Ecuador (Pacifictel)
1-800-225-528 (Toll Free)
El Salvador
800-1288 (Toll Free)
Guatemala
99-99-190 (Toll Free)

or 138-126 (Toll Free)
Honduras
800-0-123 (Toll Free)
Mexico
001-800-476-7136 (Direct)
or 01-800-288-2872 (Toll Free)
Panama
800-0109 (Toll Free)
Peru (Telephonica)
0-800-50288 (Toll Free)
Uruguay
000-411-008-5447 (Direct)
or 000-410 (Toll Free)
Venezuela
0-800-2255-288 (Toll Free)
plus 800-476-7136
plus 800-476-7136
plus 800-476-7136
plus 800-476-7136
English_Covance CLS Contact Numbers 1/4_Update: 20060109
2003 Covance CLS
Page: 88
510013_TMEA_Printed: 20070606

To call Covance CLS in Geneva from:
Monday - Friday: 8h00 - 19h00 (Geneva time = GMT +1)
Saturday:
10h00 - 17h00 (Geneva time = GMT +1)
If you need urgent assistance outside of Geneva working hours you may call
the Investigator Call Center in Indianapolis at +1 317 271 1200 (then press 2)
Austria
Luxemburg
Belgium
Netherlands
Cyprus
Norway
Denmark
Portugal
France
Slovakia
Germany
Slovenia
Hungary
Spain
Ireland
Sweden
Israel
Switzerland
Italy
United Kingdom
Liechtenstein
00 800 88 77 44 11 (Tel)
00 800 88 77 44 22 (Fax)
Croatia
0800 22 30 61 (Tel)
0800 22 30 60 (Fax)
Czech Republic
800 142 083 (Tel)

800 142 787 (Fax)
Finland
990 800 88 77 44 11 (Tel)

990 800 88 77 44 22 (Fax)
Greece
00 800 4112 871 141 (Tel)

00 800 4112 871 140 (Fax)
Latvia
800 31 43 (Tel)
800 31 01 (Fax)
Lithuania
8800 30124 (Tel)

8800 30262 (Fax)
Monaco
800 93 185 (Tel)

800 93 184 (Fax)
Poland
00 800 41 11 231 (Tel)

00 800 41 11 230 (Fax)
Russia
810 800 201 71041 (Tel)

810 800 201 81041 (Fax)
Turkey
00 800 419 871 141 (Tel)

00 800 419 871 140 (Fax)
For countries without a toll free line, please call your local telephone
operator and ask for a collect call to one of the below numbers:
English
+41 22 989 7901
French
+41 22 989 7902
German
+41 22 989 7903
Italian
+41 22 989 7904
Spanish
+41 22 989 7905
Fax
+41 22 989 7521
To call Covance CLS in South Africa from:

South Africa
0800 225 007 (Toll Free)
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To call Covance CLS in Singapore from:
China (Northern China)
10800 650 0134 (Toll Free)

(65) 6560 8793 (Tel)
(65) 6565 5901 (Fax)
Hong Kong
800 90 0792 (Toll Free)

(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
India
0008006501323
Indonesia
001803 657 617 (Toll Free)

(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
Malaysia
1800 801 842 (Toll Free)

(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
Pakistan
00 800 11065 (Toll Free)

(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
From Pakistan, dial the Singapore direct toll-free no.
(00 800 11065). At the voice prompt, enter '2' for
International Toll-Free service. Enter the telephone
no. 65608793. Call will be connected.
Philippines
1800 1651 0312 (Toll Free)

(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
Singapore
6560-8793 (Tel)
6565-5901(Fax)
South Korea
00 308 651 1353 (Toll Free)

(65) 6560-8793 (Tel)
(65) 6565-5901(Fax)
Taiwan
0080 165 1493 (Toll Free)

(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
Thailand
001 800 65 6350 (Toll Free)

(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
Vietnam
(65) 6560-8793 (Tel)

(65) 6565-5901 (Fax)
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To call Covance CLS in Sydney from:

Australia
1800 685 436 (Toll Free)

(02) 9855 5410 (Tel)
(02) 9855 5419 (Fax)
Korea
00308 610 060 (Toll Free)

612 9855 5410 (Tel)
612-9855-5419 (Fax)
New Zealand
0800 444 079 (Toll Free)

(612) 9855 5410 (Tel)
(612) 9855 5419 (Fax)
Philippines
1800 1 611 0238 (Toll Free)

612 9855 5410 (Tel)
612 9855 5419 (Fax)
Singapore
800 6161 782 (Toll Free)

612 9855 5410 (Tel)
612 9855 5419 (Fax)
Taiwan
00801 611 384 (Toll Free)

612 9855 5410 (Tel)
612 9855 5419 (Fax)
Thailand
001 800 611 1064 (Toll Free)

612 9855 5410 (Tel)
612 9855 5419 (Fax)
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US Laboratory Certifications 1/8_Update: 20060222
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COVANCE CENTRAL LABORATORY SERVICES
CURRICULUM VITAE
MARIETTA M. HENRY, MD
PERSONAL DATA:
Business Address: Covance Central Laboratory
8211 SciCor Drive
Indianapolis, IN 46214
Office: 317-273-7934
Fax: 317-273-7990
Indiana Medical License: #01021501
New York State Department of Health, Certificate of Qualification: HENRM1
EDUCATION:
1967
1965
1963
M.D. Degree - Indiana University - Bloomington, IN.

M.S. in Pathology - Indiana University - Bloomington, IN.
A.B. in Zoology with Honors - Indiana University - Bloomington, IN.
PROFESSIONAL EXPERIENCE:
January 1990 - present
Vice President of Medical Affairs and Global Laboratory Medical Director, Covance Central Laboratory
Services - Indianapolis, IN.
January 1988 - December 1989
Medical Director, Clarkson School of Medical Technology - Omaha, NE.
January 1987 - December 1989
Chairman, Department of Pathology, Clarkson Hospital - Omaha, NE. Clinical Pathologist in charge of
Microbiology, Serology, Clinical Microscopy, Laboratory Services, Phlebotomy, Chemistry, Hematology
and Blood Bank.
September 1979 - December 1989
Clinical Assistant Professor, Department of Pathology and Microbiology, University of Nebraska
Medical Center - Omaha, NE.
Participated in lecturing to medical students, pharmacy students, and medical technology students. Sat
on Residency Interview Committee.
July 1979 - December 1987
Pathologist, Bishop Clarkson Memorial Hospital - Omaha, NE.
First in charge of Microbiology, Serology, Clinical Microscopy and Phlebotomy. Later added remainder
of Laboratory as well as participated in reading of Cytology samples (PAP smears and FNS's). Rotated
on autopsy service.
July 1978 - July 1979
Fellowship in Clinical Microbiology, Department of Clinical Pathology, Indiana University Medical Center
- Indianapolis, IN.
1
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May 1975 - May 1978
Pathology residency (combined AP-CP), Indiana University Medical Center - Indianapolis, IN.
October 1973 - March 1975
Public Health Physician, Bernalillo County Health Department - Albuquerque, NM.
May 1973 - July 1973
Pathology residency, Indiana University Medical Center - Indianapolis, IN.
August 1971 - March 1972
Pediatrics residency, Indiana University Medical Center - Indianapolis, IN.
August 1970 - July 1971
Pediatrics, private practice - Sullivan, IN.
September 1969 - June 1970
Student Health Physician (part-time), Indiana University - Bloomington, IN.
October 1968 - June 1969
Staff pediatrician, Ireland Army Hospital - Ft. Knox, KY.
July 1968 - October 1968
Staff pediatrician, Marion County General Hospital - Indianapolis, IN.
September 1967 - June 1968
Pediatrics internship, Indiana University Medical Center - Indianapolis, IN.
HOSPITAL AND STAFF APPOINTMENTS:
1988 - 1989
1981 - 1989
1979 - 1989
1978 - 1979
1978 - 1979
1970 - 1971
1968 - 1969
1968
Chairman, Department of Pathology. Member of the Executive Committee of the Medical

Staff, Clarkson Hospital - Omaha, NE.
Cancer Committee (1981-1983),
Infection Control Committee (1981-1989; Chairman, 1987),
Institutional Review Board (1981, 1982, 1984; Chairman, 1985),
Pharmacy, Therapeutics and Transfusion Committee (1981-1989),
OB-Audit Committee (1984-1988),
Credentials Committee and Radiation Safety Committee (1987-1989), Clarkson HospitalOmaha, NE.
Clinical Assistant Professor, University of Nebraska Medical Center, Department of Pathology
and Microbiology - Omaha, NE.
Wishard Memorial Hospital - Indianapolis, IN.
Indiana University Medical Center - Indianapolis, IN.
Mary Sherman Hospital - Sullivan. IN.
Ireland Army Hospital - Ft. Knox, KY .
Marion County General Hospital - Indianapolis, IN.
2
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PROFESSIONAL SOCIETIES:
American Association of Clinical Chemistry
American Medical Association
American Society for Microbiology
American Society of Clinical Pathology
Clinical and Laboratory Standards Institute (formerly NCCLS)
College of American Pathologists
Drug Information Association
Infectious Diseases Society of America
MEDICAL LICENSURE:
State of Indiana - 1967 to present
State of Nebraska - 1979 to 1990
BOARD CERTIFICATION:
Certified by the American Board of Pathology in Anatomic and Clinical Pathology, 1979
Certified by the Medical Microbiology Subspecialty Board, 1980
PRESENTATIONS:
Clinical and technical presentations at pharmaceutical companies.
Member of the Covance Biomarker Expert Panel.
Drug Information Association, June 2004: Chairperson of session Global Type II Diabetes: Facts
gleaned from multiple clinical trials; Speaker Global Laboratory Testing for Type II Diabetes Clinical
Trials.
Schneider, S.; Goss, T.; Henry, M. M.; Isley, B. and Neagle, G.; Successful Implementation of Diabetes
Trials. October 2003 (Woodcliff Lake, NJ, USA).
Lockett, T.; Holland, A.; Gibson, M.; Henry, M.; Neagle, G. and Knight, M.; Effective Implementation of
Diabetes Trials. Presented at Maison de la Chimie, April 2003 (Paris, France ).
Kohler, R. B.; Bartlett, M. S.; Smith, J. W. and Henry, M. M.; Third International Symposium on
Infections in the Recovery of Leukemics from Fusarium Infections. Presented at the
Immunocompromised Host; June, 1984 (Toronto, Canada).
Henry, M. M.; Allen, S. D.; Siders, J. A.; Reynolds, J. K.; Cromer, M. D. and Fischer, J. A.; The
Susceptibility of Clinical Isolates of Clostridium difficile to New Beta Lactam and Other Antibiotics.
Presented at ICAAC, October, 1989 (Boston, MA). Extended abstract in Current Chemotherapy and
Infectious Disease, 1980.
Wheat, J.; Henry, M.; Kohler, R. and White, A.; Serologic Tests to Distinguish Colonizing from
Pathogenic Bacteria in Diabetic Patients with Foot Ulcer-Related Osteomyelitis. Presented at the
American Society for Microbiology, May 1979 (Hawaii).
Henry, M. M.; Wheat, L. J., Allen, S. D.; Siders, J. A. and White, A.; Bacteriology of Diabetic Foot UlcerRelated Infections and Osteomyelitis Using Percutaneous Bone Biopsy. Presented at the American
Society for Microbiology. May, 1979 (Los Angeles, CA).
Crussi, F. G.; Roth, L. M. and Henry, M. M.; Yolk Sac Carcinoma: The experience at the Indiana
University Medical Center. American Journal of Pathology, 1976 (Abstract). Paper presented at the
Twelfth Annual Meeting of the Pediatric Pathology Club, March 1970 (Boston, MA).
3
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PUBLICATIONS:
1. Rose, K. and van den Anker, J. N. Guide to Paediatric Clinical Research. Henry, M. M., Central
Laboratory in Paediatric Clinical Trials. 78-86 (2006)
2. Graves, Adrienne; Henry, Marietta; O'Brien, Terence P; Hwang, David G.; Van Buskirk, Amy and
Trousdale, Melvin D. In vitro susceptibilities of bacterial ocular isolates to fluorquinolones.
CORNEA, 2001.
3. Chapter: Forensic Microbiology in Forensic Pathology, Second Edition, 1991. (ASCP)
4. Chapter: Automation in Microbiology in Laboratory Instrumentation, Third Edition, 1987 (J.B.
Lippincott Company).
5. Vose, J. H.; Smith, P. W.; Henry, M. M. and Colan, D. Recurrent Streptococcus mutans
Endocarditis. American Journal of Medicine, 82:630-632 (1987).
6. Wheat, L. J.; Allen, S. D.; Henry, M. M.; Kernek, C. B; Siders, J. A.; Keubler, T.; Fineberg, N. and
Norton, J. Diabetic Foot Infections. Bacteriologic Analysis. ARCH Internal Medicine, 146:1935-1940
(1986).
7. Lee, S. C.; Henry, M. M. and Gonzales-Crussi, F. Simultaneous Occurrence of Melanotic
Neuroectodermal Tumor and Brain Heterotopia in Oropharynx. CANCER 38:249-253 (1976).
8. Kubitschek, H. M. and Cassle, Marietta. Alternative States in Control of the Constancy and Rate of
Cell Division in Saccharomyces cervisiae. EXPER. CELL RESEARCH 42:281-290 (1996).
CONTINUING EDUCATION PRESENTATIONS:
i Covance eConference Series: Pediatric Clinical Trials - Why Now? What to do? February 2002
i DIA workshop on Biomarkers. Fall, 1999 (Durham, NC)
i Drug Information Association, June 1998 - Panel Member for discussion of Quality Assurance in
Clinical Trials.
i Drug Information Association, Program Committee and Presenter, Jan 12-13, 1998. Presentation:
Use of a Central Laboratory in Clinical Trials - Solving the Problems.
i Drug Information Association, June 1997 - Panel Member for discussion of Quality Assurance in
Clinical Trials.
i Hoechst Marion Roussel Corporation, "Covance Anti-infective Capabilities and Experience", 1997.
i Pfizer Pharmaceutical Corporation, "Interpretation of Laboratory Values", 1996.
i Searle Pharmaceutical Corporation, "History, Experience, Clinical Operations and Role for In-patient
Clinical Trials", 1996.
i Searle Pharmaceutical Corporation, "The Role of a Central Laboratory for In-Patient Clinical Trials",
1996.
i Cambridge Health Conference, "Surrogate Markers for Aids", 1995.
i Indiana University School of Medicine, The Laboratory in Patient Research at the General Clinical
Research Center Workshop: "Essentials of Patient Research", 1993.
i Parke Davis Pharmaceutical Co., "Microbiology for Clinical Trials", 1993.
i Amgen Corporation, "Hematology Issues in Clinical Trials", 1992.
i G. H. Besselaar Company, "Microbiology Training", 1992.
i Faculty, Nebraska Infection Control Regional Workshops, 1983-1989.
i Lecturer, NSMT Annual Meeting, Microbiology, 1982-1989.
i Director and Faculty, Regional ASCP Workshop, Microbiology Updates, Des Moines, IA, 1984.
i Director and Faculty, Regional ASCP Workshop, Microbiology Updates, Des Moines, IA, 1983.
i Faculty, CAAMA-NSMT Microbiology Update, Omaha, NE, 1981.
i Faculty, ASCP Anaerobe Workshop, Chicago, IL 1981.
i Faculty, ASCP Anaerobe Workshop, Chicago, IL 1979.
4
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CONTINUING EDUCATION ACTIVITIES:
2006 Drug Informaton Associateion (DIA), 42nd annual meeting
Department of Health & Human Services, Clinical Laboratory Diagnostics for Invasive
Aspergillosis
2005 Infectious Diseases Society of America (IDSA), annual meeting.
2004 NCCLS Subcommittee on Antimicrobial Susceptibilities, January.
Drug Information Association (DIA), 39th annual meeting.
American Society for Bone and Mineral Research, 26th annual meeting.
2003 NCCLS Subcommittee on Antimicrobial Susceptibilities, January and June.
Infectious Diseases Society of America (IDSA), annual meeting.
ICAAC, ASM's 43rd Annual Meeting on Infectious Diseases, September.
Interscience Conference on Antimicrobial Agents in Chemotherapy (ICAAC), 42nd annual.
2001 World Courier Biomedical Seminar on the Transportation of Infectious & Diagnostic
Substances.
Interscience Conference on Antimicrobial Agents in Chemotherapy (ICAAC), 41st annual.
NCCLS Subcommittee on Antimicrobial Susceptibilities, January and June.
Seventh National Conference on AIDS and Related Infections.
American Society for Microbiology.
AIDS Clinical Trials Group.
Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
Sixth National Conference on AIDS and Related Infections.
AIDS Clinical Trials Group.
Infectious Diseases Society of America (IDSA).
1998 Drug Information Association Meeting.
NCCLS Subcommittee on Antimicrobial Susceptibilities.
Fifth National Conference on AIDS and Related Infections.
12th Annual International World Conference on AIDS.
AIDS Clinical Trial Group.
Clinical Cytometry Forum.
Interscience Conference on Antimicrobial Agents and Chemotherapy ( ICAAC).
5
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CONTINUING EDUCATION ACTIVITIES:
1997 Drug Information Association Meeting.
NCCLS Subcommittee on Antimicrobial Susceptibilities.
American Academy of Allergy Asthma and Immunology Meeting.
AIDS Clinical Trial Group.
Clinical Cytometry Forum.
Infectious Diseases Society of America.
Signed by : _____________________________________________________
Date : __________________________________________
6
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GLOSSARY
Ambient: room temperature.

Analyte: a substance or chemical constituent of any body fluid that is analyzed.
Analyte Specific Reagents (ASR): This test was developed and its performance characteristics determined
by Covance Central Laboratory Services. It has not been cleared or approved by the U. S. Food and Drug
Administration. The FDA has determined that such clearance or approval is not necessary. Covance CLS is
certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform
high complexity clinical laboratory testing.
Blinding: some protocols require that the results of one or more laboratory tests performed at Covance CLS
are kept blinded when, for example, a certain value could give an indication of which treatment the patient is
receiving. The results are therefore not communicated to the investigator or sponsor during the course of the
study.
Centrifuge: an apparatus used to separate particles in suspension by centrifugal force. Processing a blood
specimen in a centrifuge will separate serum or plasma from blood cells. Centrifuge approximately 10 to 15
minutes at full speed (for the standard table top model) or at 1500 g to separate the blood specimen. Please
consult your protocol for special specimen collection procedures that require centrifugation at higher speed.
Clotted blood: results cannot be reported from such a specimen. This cancellation refers to small blood clots
consisting of RBCs, WBCs, platelets and clotting factors which alter the proportions of cellular and soluble
elements remaining in the specimen.
Consumed in testing: this phrase is used when the entire volume of specimen is used for testing, yet a valid
result is not obtained. Typically, this occurs when a small amount of specimen is originally received, or a
questionable result is obtained and insufficient volume is available to repeat the test.
Covance Central Laboratory Services reference ranges: individualized test reference ranges established
specifically for pharmaceutical clinical trial patients. They may be age and sex specific.
Delta: a flag alert indicating that a laboratory result represents a statistically significant change from the
patients baseline value; +d is the designation if the result is a positive change from baseline, -d is the
designation if the result is a negative change from baseline or pre-drug level. These flags appear to the left of
the result on the laboratory report. These results are not telephoned to the investigator or sponsor.
Dye interference: a phrase used when the color of the urine is such that the dipstick chemistry tests are
unable to be read.
Error in specimen identification: this indicates that the accession number and/or the patient identifier written
on the container does not match the accession number and/or the patient identifier written on the requisition
form.
Exclusion flags: EX is used to indicate an exclusion value according to the exclusion criteria set by the
sponsor according to protocol requirements. This flag will appear to the left of the result on the laboratory
report.
Frozen: this term indicates the specimen was properly maintained in a frozen state, preferably below -20 C.
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GLOSSARY (CONTINUED)
Frozen specimens require dry ice to maintain a frozen state during shipment. Avoid a frost-free refrigerator
during storage of specimens. Please consult your investigator manual for proper storage instructions.
Hemolysis: indicates the rupture of red cells with release of hemoglobin and other analytes into the specimen.
Hemolysis will interfere with the performance of particular tests, which will result in specific cancellations.
High and Low flags: H for high and L for low flags appear to the right of the test result on the laboratory
report if the result falls outside the reference range. High and low results are not telephoned to the investigator
or sponsor.
Improper ratio of blood to anticoagulant: this is the result of the lavender or blue top tube not being filled
completely during collection, causing inconsistent results.
Incorrect specimen type: this phrase indicates that an incorrect specimen type was submitted, based on
protocol testing requirements, (e.g. serum received when plasma is required or vice versa, urine is received
for serum, etc.)
Invalid: in terms of calculations, an invalid comment would indicate that one component of the calculation
renders the calculation of a meaningful result impossible. Can also be used when the result is not reasonable
due to specimen irregularities; used when one component of a calculation is out of stability. Example: MCV,
MCHC and HCT resulted as invalid if specimen is greater than 60 hours old.
Investigational use only (IUO): the manufacturer of the reagent has informed us the performance
characteristics of this assay have not been fully established as required by the Food and Drug Administration
(FDA) regulations as outlined in 21 CFR (Code of Federal Regulations) 809 (In Vitro Diagnostic Products For
Human Use). Accordingly, test results for this assay may not presently be used as a diagnostic tool alone,
without confirmation by another medically established procedure.
Lipemic: serum or plasma with a turbid or milky appearance. This is caused by an elevation in triglycerides
and may be seen in a nonfasting specimen or in certain disorders of lipid metabolism. Lipemia will interfere
with several laboratory tests.
Microclots: Microclots may be reported for the platelet count when a valid count cannot be obtained due to
platelet clumping. Please consult your investigator manual for proper mixing instructions.
Myeloperoxidase deficiency: a common inherited disorder of neutrophil function. It is detected when using
an automated hematology instrument which performs a white blood cell differential using a peroxidase channel.
Patients rarely know they have the disorder and usually require no treatment. Myeloperoxidase deficiency can
also be acquired and is mostly seen in acute myelogenous leukemia, myelodysplastic syndrome and Battens
disease.
Panic alerts: HP for a high panic or LP for a low panic alert. They are associated with critical laboratory
values which may indicate medical emergencies. These flags appear to the right of the test result on the
laboratory report. These values are telephoned immediately to the investigator and confirmation of receipt
for these critical results must be obtained.
Pharmacokinetics: the study of the action of drugs within the body, including the routes and mechanisms of
absorption, distribution, excretion, and metabolism; onset of action; duration of effect; biotransformation;
effects and routes of excretion of the metabolites of the drug; rate of appearance and disappearance in blood,
urine or other body tissues.
Plasma: the fluid portion of the blood in which blood cells are suspended. This yellowish fluid separates from
a blood specimen which was mixed with an anticoagulant (e.g. EDTA, heparin, citrate or other anticoagulants)
upon centrifugation.
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GLOSSARY (CONTINUED)
Prolonged cell contact: the condition which occurs when a serum is allowed to remain in contact with cells
for a prolonged period of time. This may occur at the investigator site prior to centrifugation or may be due to
red blood cells present in the serum or plasma during transport. A combination of cellular metabolism and
cellular damage produces a pronounced decrease in serum glucose and elevations in potassium and
phosphorus.
Quantity not sufficient: this phrase is used when an insufficient sample volume is received for testing.
Refrigeration during collection: This phrase means the specimen must be 2-8C during the entire collection
procedure, (e.g. 24 hour urine collection). Please consult your specific collection instructions.
Repeat reactive (positive), confirmed: screening testing indicates specimen was positive; confirmation by a
more specific test also indicates that the specimen was positive. Specimen result is positive for the analyte.
Repeat reactive (positive), unconfirmed: screening testing indicates specimen was positive; however,
specific confirmation testing was not positive. Results are indeterminate. Recollection may be requested.
Sample drawn in expired tube: specimen received in expired container - Due to regulatory requirements,
Covance cannot report results from collection containers that are past the expiration date placed on the
container from the manufacturer. Results from expired containers will be cancelled.
Serum: the clear fluid portion of the blood obtained after the cells have formed a clot and the specimen is
centrifuged. This clear, straw-colored liquid portion of the blood does not contain fibrinogen or blood cells.
Sample is collected in a tube which does not contain an anticoagulant.
Short draw collection tubes: Covance is providing short draw collection tubes for this study. The short draw
Vacutainer brand tubes with Hemogard Closure are designed for collecting a small volume of blood. The short
draw tubes are the same size as adult size vacutainer tubes but contain only enough vacuum to fill the tube to
the indicator line. Short draw tubes fill more slowly than full volume tubes due to a lower vacuum.
Specimen received ambient: this phrase is used when a specimen intended for refrigerated or frozen
shipment is received at Covance Central Laboratory Services not in required shipping condition. Reasons
include: Dry ice evaporated, too little dry ice used, incorrectly packaged for frozen shipment, shipment
delayed, etc.
Specimen received beyond stability: this indicates too much time has elapsed to perform a valid assay
when the specimen is received at Covance Central Laboratory Services. The test will be cancelled if the
specimen is received beyond the established stability period for a given analyte. It can also indicate that the
specimen should have been received frozen but was received ambient and the test will be cancelled as
received beyond stability since the ambient stability has expired.
Telephone alerts: HT for a high telephone alert or LT for a low telephone alert. They are associated with
laboratory values which may indicate clinical problems and need critical evaluation by the investigator. These
values are telephoned to the investigator site and mailed to the sponsor. Telephone alerts are phoned to the
sponsor if Covance Central Laboratory Services fails to reach the investigator after at least two attempts.
TNTC: Too Numerous To Count. Too many cells to be counted under high power field microscopy. For
example: on a laboratory report for urinalysis, the red blood cells (RBC) and/or the white blood cells (WBC)
in the urine microscopy can be "TNTC".
Unable to verify test result: this cancellation is applied to specimens that fail the required confirmatory
analysis following the initial analysis.
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Central Laboratory

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2003 Covance CLS

English_Table of Contents_Update: 20070605

Please check kit expiration dates before

A unique accession number is assigned to each

Complete the labels with appropriate identifiers

Each container label is pre-printed with an

English_Kit Information_Update: 20031021

STABILITIES FOR ANALYTES IN SPECIMENS

Listed below are stabilities at ambient storage.

2003 Covance CLS

English_Stabilities for Analytes in Specimens_Update: 20061030

CUSTOMS CLOSED/PUBLIC HOLIDAYS

For sites with 48-hour inbound transit:

Holiday reminders are also available on the Covance website:

English_Custom Closed/Public Holidays 1/3_Update: 20060707

2003 Covance CLS

CUSTOMS CLOSED/PUBLIC HOLIDAYS

New Year's Day

For sites in US and Canada

Europe, Middle East and Africa (specimens sent to Geneva)

New Year's Day

English_Custom Closed/Public Holidays 2/3_Update: 20060420

2003 Covance CLS

CUSTOMS CLOSED/PUBLIC HOLIDAYS

Asia (specimens sent to Singapore)

New Year's Day

Taiwan Customs are closed on Saturday/Sunday.

Do not schedule patients

Australia, New Zealand and Asia (specimens sent to Sydney)

English_Custom Closed/Public Holidays 3/3_Update: 20060420

2003 Covance CLS

New Year's Day

LABORATORY VISIT SCHEDULE FOR PROTOCOL 2-0

Kit - Early Termination

2003 Covance CLS

English_Visit Test Schedule_Update: 20070605

ANALYTES BY GROUPS FOR PROTOCOL 2-0

HEMATOLOGY & DIFFERENTIAL PANEL

DMI/ EXPLORATORY (CITRATE)

2003 Covance CLS

English_Analytes By Groups_Update: 20070605

SPECIMEN COLLECTION PROCEDURES FOR PROTOCOL 2-0

Recommendations regarding the proper use of centrifuge:

2003 Covance CLS

English_Specimen Collection Procedures_Update: 20070605

SPECIMEN COLLECTION PROCEDURES FOR PROTOCOL 2-0

2003 Covance CLS

English_Specimen Collection Procedures_Update: 20070605

SPECIMEN COLLECTION PROCEDURES FOR PROTOCOL 2-0

2003 Covance CLS

English_Specimen Collection Procedures_Update: 20070605

SPECIMEN COLLECTION PROCEDURES FOR PROTOCOL 2-0

2003 Covance CLS

English_Specimen Collection Procedures_Update: 20070605

SPECIMEN COLLECTION PROCEDURES FOR COAGULATION TESTING

2003 Covance CLS

English_Coagulation Testing_Update: 20070514

SPECIMEN COLLECTION PROCEDURES FOR COAGULATION TESTING

2003 Covance CLS

English_Coagulation Testing_Update: 20070514

BLOOD SMEAR PREPARATION

1. Write appropriate identifiers on the frosted