Boditech Med Inc.
: INS-CA-CN
i-CHROMA hsCRP-All in one
ImmunoAssay for Quantitative and Point of Care
Testing (POCT) Quick Measurement of high
sensitivity C-Reactive Protein (hsCRP) and C-
Reactive Protein (CRP) in Human
Serum/Plasma/Whole blood with i-CHROMA
Reader System.
INTENDED USE
i-CHROMA hsCRP-All in one along with i-CHROMA Reader is
a fluorescence immunoassay that measures hsCRP and CRP in
serum, plasma, and whole blood. The test is used as an aid to
predict future cardiovascular diseases (CVD) as well as to see
infection and inflammation.
INTRODUCTION
C-Reactive Protein (CRP) is synthesized by the liver .The CRP level
may rise from a normal level of <5 mg/L to 500 mg/L during the
bodys general, non-specific response to infectious and other acute
inflammatory events.
For some time, the measurement of CRP concentration has been used
as a clinical tool for monitoring autoimmune diseases and infectious
processes, such as differential Diagnosis of bacterial infection and viral
infection, therapy monitoring,and rheumatoid arthritis1,2.
It has recently been suggested that along with serum cholesterol, may
be marker of diagnosis in cardiovascular diseases (acute myocardial
infarction). And, hsCRP is emerging as the strongest and most
independent predictive risk factor for CVD7,8.
A statement regarding use of high sensitivity C-reactive protein to
assess risk of cardiovascular diseases without inflammatory events:
lower than 1.0 mg/L, low risk.
between 1.0 and 3.0 mg/L, average risk.
higher than 3.0 mg/L, high risk.
For infection and inflammatory events, CRP normal reference:
10.0mg/L.
PRINCIPLE
i-CHROMA hsCRP-All in one is based on fluorescence
immunoassay technology9, 10. i-CHROMA hsCRP-All in one uses
a sandwich immunodetection method, such that by mixing
detection buffer with blood specimen in test vial, the fluorescence-
labeled detector anti-hsCRP antibody in buffer binds to hsCRP
antigen in blood specimen. As the sample mixture is loaded onto
the sample well of the test device and migrates the nitrocellulose
matrix of test strip by capillary action, the complexes of detector
antibody and hsCRP are captured to anti-hsCRP sandwich pair
antibody that has been immobilized on test strip. Thus the more
hsCRP antigen is in blood specimen, the more complexes are
accumulated on test strip. Signal intensity of fluorescence of
detector antibody reflects amount of hsCRP captured and is
microprocessed from i-CHROMA Reader to show hsCRP
concentration in blood specimen. The default result unit of i-
CHROMA hsCRP-All in one is displayed as an mg/L from i-
CHROMA Reader. The working range and the detection limit of i-
CHROMA hsCRP-All in one system are 0.5-200 mg/L. and 0.1
mg/L, respectively.
Document No.
COMPOSITION OF REAGENTS
i-CHROMA hsCRP-All in one consists of Test Device and
Detection Buffer. Test Device is individually sealed with a
desiccant in aluminum pouch, and Detection Buffer is packed and
delivered separately from Test Device in a Styrofoam box filled
with ice pack.
y Test Device contains a test strip in which murine monoclonal
antibody against human CRP and of rabbit IgG has been
immobilized on the test and on the control line of strip,
respectively.
y Detection Buffer contains fluorescence-labeled anti-CRP
(Mouse monoclonal), fluorescence-labeled anti-rabbit IgG,
BSA as a stabilizer, and Sodium Azide as a preservative in PBS.
WARNINGS AND PRECAUTIONS
y IVD For In Vitro Diagnostic Use.
y Carefully follow the instructions and procedures described in
this insert. REF Catalog No. i-CHROMA hsCRP-
25/50/100/200
y Dont use Test Device if its lot # does not match with ID Chip
# that is inserted onto the instrument.
y i-CHROMA hsCRP-All in one is only operational in i-
CHROMA Reader. And tests should be applied by
professionally trained staff working in certified laboratories at
some remove from the patient and clinic at which the sample(s)
is taken by qualified medical personnel.
y LOT Neither inter-change materials from different
product lots nor use beyond the expiration date. The use
of medical device beyond expiration date may affect on
test result.
y i-CHROMA hsCRP-All in one Test Device should
remain in its original sealed pouch until ready to use. Do
not use the Test Device if the pouch is damaged or the
seal is broken. Discard after single use.
y CRP Test Device and Reader should be used away from
vibration and magnetic field. During normal usage, i-
CHROMA hsCRP-All in one may introduce minute vibration,
which should be regarded normal.
y Use separate clean pipette tips and sample vials for
different specimens. The pipette tips and sample vials
should be used for one specimen only. Discard after
single use.
y Blood specimens, used test devices, pipette tips and
sample vials are potentially infectious. Proper laboratory
safety techniques, handling and disposal methods should
be followed in accordance with standard procedures and
relevant regulations observed by microbiological hazard
materials.
y i-CHROMA hsCRP-All in one can be used as diagnosis and
assessment for infection and inflammation or high risk of CVD.
The results should be interpreted by the physician along with
clinical findings and other laboratory test results.
y Do not smoke, eat, or drink in areas in which specimens or kit
reagents are handled.
Boditech Med Inc.
STROAGE AND STABILITY
y Store the detector buffer in a refrigerator at 2 - 8C. The
detection buffer is stable up to 18 months.
y Once removed from refrigerator, allow the Detection Buffer for
10 minutes to return to room temperature before testing.
y Store i-CHROMA hsCRP-All in one Test Device at 4-
30C in its sealed pouch. i-CHROMA hsCRP-All in one
test device is stable for 18 months (while in the sealed
pouch) if stored at 4-30C.
y If stored in a refrigerator, allow a minimum of 10 minutes for
the Test Device to reach room temperature while it is in the
sealed pouch.
y Do not remove the device from the pouch until ready to use.
The Test Device should be used immediately once opened.
y The storage and shipping of Test Kit should be complied as
indicated in manual. However, it is remotely possible that only
part of Test Kit is affected by stability problems.
SAMPLE COLLECTION AND PREPARATION
The test can be performed with either serum or plasma or whole
blood.
y For serum sample, collect the blood in a tube without
anticoagulant and allow to be clotted. Remove the serum from
the clot as soon as possible to avoid hemolysis. For plasma
sample, collect the blood in a tube treated with EDTA.
Anticoagulants other than EDTA for plasma specimen have not
been evaluated. If testing cannot be conducted within an hour
after preparation of specimen, the serum/plasma should be
stored at -20o C until tested. In case of use whole blood, apply it
immediately after specimen was taken.
y The specimen must be at room temperature and be
homogeneous before testing. Frozen specimens must be
completely thawed, thoroughly mixed, and brought to room
temperature prior to testing. If specimens are to be shipped,
they should be packed in compliance with regulations.
y It is recommended to avoid using severely hemolyzed
specimens whenever possible. If a specimen appears to be
severely hemolyzed, another specimen should be obtained and
tested.
MATERIALS PROVIDED
Boditech Med Inc. i-CHROMA hsCRP-All in one
REF Catalog No. i-CHROMA hsCRP-25/50/100/200
Box contains:
Test Devices 25/50/100/200T/box
Detection Buffer 25/50/100/200 Tubes (500 L/tube)
Sample collector 25/50/100/200/box
ID Chip 1/box
Insert 1/box
MATERIALS REQUIRED BUT NOT PROVIDED
i-CHROMA Reader REF Catalog No. FR-203
Document No. : INS-CA-CN
Thermal Printer
i-CHROMA hsCRP Control(L, H)
Lancet (if whole blood)
PROCEDURE
1. Set a Test Device on a dust-free clean place.
2. Check/insert ID Chip onto the instrument. Make sure that the
Test Device lot # matches with ID Chip #.
3. Take out a tube containing Detection Buffer from refrigerator
and leave it at room temperature for a couple of minutes.
4. Make a puncture on the top of the detector tube by inserting an
empty blood collection capillary
5. Draw whole blood, serum, plasma, or control with a sample
collector (10 L).
6. If necessary, wipe out the excess blood outside of the capillary
with paper towel or Kimwipes
7. Assemble the capillary and the tube into one.
8. Shake the assembled tube gently 5 times by inversion to take the
blood out of capillary.
9. Remove the cap off the top of tube. Discard two drops of
reagent onto the paper towel before applying to the cartridge.
10. Apply only two drops onto the sample well of a cartridge.
11. Leave it in Room Temperature 3 mins.
12. Insert Test Device onto the holder of i-CHROMA Reader.
Make sure direction of Test Device and push the device
back all the way. Instrument will automatically scan the Test
Device.
13. Read the results on the display screen of i-CHROMA Reader
or tear out the print for record.
Refer to i-CHROMA Reader Operation Manual for the
complete instructions on use of the Test.
RESULT
i-CHROMA Reader calculates hsCRP test results automatically
and displays hsCRP concentration on the screen as form of mg/L.
For further information, refer to the Operation Manual for i-
CHROMA Reader.
Quality Control
Quality Control
y A quality control test using commercially available controls
should be performed as a part of good testing practice, to
confirm the expected QC results, to confirm the validity of the
assay, and to assure the accuracy of patient results. If you want
to perform QC of Test Kit, we recommend using Kamiya CRP
control.
y A quality control test should be performed at regular intervals,
and before using a new kit with patient specimens, controls
Boditech Med Inc. Document No. : INS-CA-CN

should be tested to confirm the test procedure, and to verify the
tests produce the expected QC results. QC specimens should also
be run whenever there is any question concerning the validity of
results obtained. Upon confirmation of the expected results, the
test device is ready to use with patient specimens. Control
standards are not provided with this test kit. For information
about obtaining the controls, contact Boditech Med Incorporates
Technical Services for assistance.
3. Imprecision: For the intra-assay imprecision, 20 replicates were
tested at each control sample. For the inter-assay imprecision,
tests were conducted on 10 sequential days, with 10 runs per day
and with 10 replicates at each CRP concentration.
Imprecision of i-CHROMA hsCRP-All in one
CRP (mg/L) Intra-assay Inter-assay

Mean S.D CV% Mean S.D CV%

Procedure Control
y Each i-CHROMA hsCRP Test Device contains internal
control that satisfies routine quality control requirements. This
internal control is performed each time a patient sample is
tested. This control indicates that the test device was inserted
and read properly by i-CHROMA Reader. An invalid result
from the internal control causes an error message on i-
CHROMA Reader indicating that the test should be repeated.
LIMITATIONS OF THE PROCEDURE
y The results of i-CHROMA hsCRP-All in one should be
evaluated with all clinical and laboratory data available. If CRP
Test results do not agree with the clinical evaluation, additional
tests should be performed.
y The false positive results include cross-reactions with some
components of serum from individual to antibodies; and non-
specific adhesion of some components in human blood that
have similar epitopes to capture and detector antibodies. In the
case of false negative results, the most common factors are:
non-responsiveness of antigen to the antibodies by that certain
unknown components are masking its epitope, such that antigen
cannot be seen by the antibodies; instability of CRP antigen,
resulting in degradation with time and, or temperature, such
that they become no longer recognizable by antibodies; and
degraded other test components. The effectiveness of the test is
highly dependent on storage of kits and sample specimens at
  
  
  
4. Linearity: The high pool (~200 mg/L) was diluted with the very
low pool (~0.50 mg/L) to the following final percentages; 100%,
75%, 50%, 25%, 10%, 5% and 0%. Sample was assayed in
triplicate in one analytical run at each CRP level. The coefficient
of linear regression was R=0.997.
5. Comparability: The CRP concentrations of 150 clinical
specimens were quantified independently with i-CHROMA
hsCRP-All in one and TBA 200FR (Toshiba Inc.) and BNII
ProSpec (Dade Behring Inc.) automatic analyzer. While the
whole blood was used for i-CHROMA hsCRP-All in one, the
serums were used for TBA 200FR and BNII ProSpec. The test
results were compared and their compatibilities were
investigated with linear regression and correlation of coefficient
(R). i-CHROMA hsCRP-All in one was comparable well to
other methods (R=0.988 and R=0.989) 10.
50
y=1.05727X+0.26972
R=0.989
40

optimal conditions.
i-CHROMA (mg/l)

30

y Plasma using anticoagulants (e.g. heparin or citrate) other than

EDTA has not been evaluated in i-CHROMA hsCRP-All in 20

one and thus should not be used.

10
y Other factors may interfere with i-CHROMA hsCRP-All in
one and may cause erroneous results. These include technical 0
or procedural errors, as well as additional substances in blood
specimens. 0 10 20 30 40 50
BN II ProSpec (mg/l)

PERFORMANCE CHARACTERISTICS

50
1. Analytical Sensitivity: Analytical sensitivity means the lowest
concentration of CRP that the test system can detect with 40
y=0.9748X-0.14791
R=0.988
CV<20%. Analytical sensitivity of i-CHROMA hsCRP-All in
one was determined by testing 10 times with three lots of
i-CHROMA (mg/l)

30

reagents. Analytical sensitivity of i-CHROMA hsCRP-All in 20

one system was 0.5 mg/L.

10

2. Specificity: Other bio-molecules, such as Hb, CEA, AFP, ALT,

Troponin I, CK-MB, Albumin, and serum amyloid P component 0

were added to test specimen with much higher level than their 0 10 20 30 40 50

physiological level in normal blood. There was no significant TBA 200FR (mg/l)

interference with the CRP measurement, nor was their any

significant assay cross-reactivity with those bio-molecules tested. Tracebility: Traceable to CAP/BCR/IFCC Reference Preparation for CRM
470.
Boditech Med Inc. Document No. : INS-CA-CN

REFERENCES
Manufacture Address:
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T. +82-33-243-1400
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F. +82-33-243-9373
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upon observance of Boditech Med Inc. published directions with
respect to the use of Boditech Med Inc. products.

For Technical Assistance call

Boditech Med Inc.s
iCHROMA Reader Technical Services at
Tel: +82-33-243-1400
E-mail: support@boditech.co.kr

Boditech Med Incorporated

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