HIV Ag/Ab Combo

E
2G83-20
34-9962/R8
B2G830
Read Highlighted Changes
Revised March, 2008

HIV Ag/Ab Combo

Customer Service
For additional product information, please contact your local customer service organization.
This package insert must be read carefully prior to use. Package insert instructions must be carefully followed. Reliability
of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

Key to symbols used

List Number
Reagent Pack
In Vitro Diagnostic Medical
Device
Lot Number Reaction Vessels

Expiration Date
Matrix Cells
Store at 2-8°C

Sample Cups
CAUTION: Consult
accompanying documents
Consult instructions
Manufacturer for use

See REAGENTS section for a full explanation of symbols used in reagent

component naming.

ABBOTT
Diagnostics Division

1
NAME
AxSYM HIV Ag/Ab Combo
INTENDED USE
AxSYM HIV Ag/Ab Combo is a microparticle enzyme immunoassay
(MEIA) for the simultaneous qualitative detection of antibodies to human
immunodeficiency virus type 1 and/or type 2 (HIV-1/HIV-2) and HIV p24
antigen in human serum or plasma. AxSYM HIV Ag/Ab Combo is used as
an aid in the diagnosis of HIV infection. AxSYM HIV Ag/Ab Combo does
not discriminate between HIV-1 and HIV-2 antibody reactivity or HIV p24
antigen reactivity.
SUMMARY AND EXPLANATION OF THE TEST
Acquired immunodeficiency syndrome (AIDS) is caused by two types of
human immunodeficiency viruses, collectively designated as HIV.1-7
HIV is the etiologic agent of AIDS.1,3,6,7 HIV is transmitted by sexual
contact, exposure to blood or blood products, and prenatal or perinatal
infection of a fetus or newborn, respectively.8 Antibodies against HIV are
nearly always detected in AIDS patients and HIV infected asymptomatic
individuals,8,9 and HIV nucleic acid (RNA and/or proviral DNA) is always
detected in AIDS patients and seropositive individuals.8,10
Phylogenetic analysis classifies HIV-1 into groups M (major), N (non-M,
non-O), and O (outlier).4,5 Group M viruses have spread throughout the
world to cause the global AIDS pandemic. In contrast, groups N and O are
relatively rare and endemic to west central Africa.11-17 However, group O
infections have been identified in Europe and the USA.18-22 HIV-1 group
M is composed of genetic subtypes (A, B, C, D, F, G, H, J, and K) and
circulating recombinant forms (CRFs).5,23 The geographic distribution and
regional predominance of HIV-1 subtypes and CRFs vary. All subtypes and
many recombinant strains exist in Africa with CRF02_AG the predominant
strain in west and west central Africa, subtypes A, C, and D predominant
in east central Africa, and subtype C predominant in southern Africa.23-28
HIV-1 subtype B is the predominant subtype in the USA, Europe, Japan,
and Australia. However, a significant percentage of new HIV-1 infections
in Europe are caused by non-B subtypes.29,30 In Asia, subtype C is found
in India, and CRF01_AE (formerly called subtype E) and subtype B are
found in Thailand and southeast Asia.31 South America predominantly
has subtypes B and F.32,33
Human immunodeficiency virus type 2 (HIV-2) is similar to HIV-1 in
its structural morphology, genomic organization, cell tropism, in vitro
cytopathogenicity, transmission routes and ability to cause AIDS.6-8
However, HIV-2 is less pathogenic than HIV-1, and HIV-2 infections have
a longer latency period with slower progression to disease, lower viral
titers, and lower rates of vertical and horizontal transmission.34-37 HIV-2 is
endemic to west Africa but HIV-2 infections, at a low frequency compared
to HIV-1, have been identified in the USA, Europe, Asia, and other regions
of Africa.31,37 HIV-2 is classified into genetic subtypes A-G with most
infections caused by subtypes A and B.38,39
The key immunogenic protein and antigenic target for serodetection of
HIV infection is the viral (HIV) transmembrane protein (TMP). Antibodies
against the TMP (anti-TMP) consistently are among the first to appear
at seroconversion of HIV infected individuals.9,39-43 The anti-TMP
response remains relatively strong throughout the course of the disease,
as evidenced by the near universal presence of antibodies against the
TMP in asymptomatic and symptomatic stages of HIV infection.9,39-44
TMPs from HIV-1 groups M and O and HIV-2 are represented in AxSYM
HIV Ag/Ab Combo on the solid phase and in the probe by three pairs of
recombinant proteins and two synthetic peptides derived from native TMP
sequences. The rationale for including three pairs of TMPs is derived from
the genetic diversity within HIV-1 and between HIV-1 and HIV-2.5 Serologic
studies indicate that although HIV-1 and HIV-2 share multiple common
epitopes in their core antigens, the envelope glycoproteins are much less
cross-reactive.7,45-49 Antibodies elicited against the TMP (or portions of
the TMP) of a viral strain within one group or type may react well, poorly,
or not at all with the TMP (or portions of the TMP) from a viral strain of
a different group or type.15,50-55 An exception may be antibodies elicited
against HIV-1 group N.11,12
Early after infection with HIV, prior to seroconversion, HIV antigen(s) may
be detected in serum or plasma specimens.55-63 The HIV structural protein
most often used as the marker of antigenemia is the core protein, p24. The
AxSYM HIV Ag/Ab Combo employs pairs of mouse monoclonal (anti-) p24
antibodies on microparticles and in the probe to detect HIV p24 antigen
prior to seroconversion, thereby decreasing the seroconversion window
and improving early detection of HIV infection.
2
Specimens that are initially reactive in the AxSYM HIV Ag/Ab Combo MEIA
should be retested in duplicate. Repeat reactivity is highly predictive of
the presence of HIV-1 and/or HIV-2 antibodies and/or HIV p24 antigen.
However, as for all enzyme immunoassays, AxSYM HIV Ag/Ab Combo may
yield nonspecific reactions due to other causes, particularly when testing
in low prevalence populations. A repeatedly reactive specimen should be
investigated further in sensitive, supplemental HIV specific tests, such
as immunoblots, antigen tests, and HIV nucleic acid tests. Supplemental
testing of repeat reactive specimens obtained from individuals at risk
for HIV infection usually confirms the presence of HIV antibodies or
HIV antigen, and HIV nucleic acid. A full differential diagnostic work-up for
the diagnosis of AIDS and AIDS-related conditions includes an examination
of the patient’s immune status and a clinical history.
BIOLOGICAL PRINCIPLES OF THE PROCEDURE
AxSYM HIV Ag/Ab Combo is based on MEIA technology utilizing
recombinant HIV (E. coli) antigens and HIV p24 monoclonal (mouse)
antibodies coated on microparticles to capture antibodies against HIV-1/
HIV-2 and HIV p24 antigen, respectively. Captured antibodies/antigen react
with biotin-labeled recombinant antigens, peptides, and p24 monoclonal
antibodies. The biotin-labeled complexes are detected using an anti-biotin:
alkaline phosphatase conjugate. Sample and all AxSYM HIV Ag/Ab Combo
reagents required for one test are pipetted by the sampling probe into
designated wells of a reaction vessel (RV) in the sampling center. The
RV is immediately transferred into the processing center. Further pipetting
is done in the processing center by the processing probe. The reactions
occur in the following sequence:
• A reaction mixture is formed by combining specimen diluent, sample,
and microparticles coated with recombinant antigens and HIV p24
monoclonal antibodies in the sample well of the reaction vessel.
• When human antibodies to HIV-1/HIV-2 or HIV p24 antigen are present
in the sample, they bind to the coated microparticles, forming antigen-
antibody complexes on the microparticles.
• A portion of the reaction mixture (containing microparticles) is
transferred to the matrix cell.
• The matrix cell is washed to remove materials not bound to the
microparticles.
• Biotinylated recombinant antigens, synthetic peptides, and HIV p24
monoclonal antibodies are dispensed onto the matrix cell, forming
immune complexes composed of recombinant antigen-human
antibody-biotinylated antigen or monoclonal antibody-p24 antigen-
biotinylated monoclonal antibody.
• The matrix cell is washed to remove materials not bound to the
microparticles.
• The anti-biotin: alkaline phosphatase conjugate is dispensed onto the
matrix cell and binds with the immune complexes.
• The matrix cell is washed to remove materials not bound to the
microparticles.
• The substrate, 4-Methylumbelliferyl phosphate, is added. The
alkaline phosphatase-labeled conjugate catalyzes the removal of a
phosphate group from the substrate, yielding the fluorescent product,
4-Methylumbelliferone. This fluorescent product is measured by the
MEIA optical assembly.
The presence or absence of antibodies to HIV-1/HIV-2 and/or HIV p24
antigen in the sample is determined by comparing the rate of formation of
fluorescent product to the cutoff rate which is previously calculated using
the AxSYM HIV Ag/Ab Combo Index Calibrator. If the rate of formation of
fluorescent product in the sample is greater than or equal to the cutoff
rate, the sample is considered reactive for antibodies and/or p24 antigen.
For further information regarding MEIA technology, refer to the AxSYM
System Operations Manual, Section 3.
REAGENTS
REAGENT KIT, 100 TESTS
AxSYM HIV Ag/Ab Combo Reagent Pack (2G83-20)
• 1 Bottle (6.8 mL) HIV-1/HIV-2 antigen/antibody coated microparticles
in TRIS buffer. Minimum concentration: 0.025% solids. Preservative:
sodium azide. (Reagent Bottle 2)
• 1 Bottle (14.3 mL) biotinylated probes: HIV-1/HIV-2 antigens and
anti-HIV p24 antibodies in TRIS buffer with surfactant, protein blockers,
stabilizers, and 10% goat serum. Minimum concentration: 100 ng/mL.
Preservatives: sodium azide and ProClin 300. (Reagent Bottle 3)
• 1 Bottle (11.7 mL) anti-biotin (rabbit): alkaline phosphatase conjugate
in TRIS buffer with protein stabilizers. Minimum concentration: 0.05 μg/mL.
Preservative: sodium azide. (Reagent Bottle 1)
• 1 Bottle (38.2 mL) Specimen Diluent in TRIS buffer with surfactant,
protein blockers, and stabilizers. Preservatives: sodium azide and
ProClin 300. (Reagent Bottle 4)
Index Calibrator
• 1 Bottle (4.3 mL) AxSYM HIV Ag/Ab Combo Index
Calibrator. Recalcified human plasma, nonreactive for HBsAg,
HIV-1 RNA or HIV-1 Ag, anti-HCV, and anti-HIV-1/HIV-2. Preservative:
sodium azide. Dye: green (Yellow No. 23 and Blue No. 9).
CONTROLS
AxSYM HIV Ag/Ab Combo Controls: (NEG, PC1, PC2, VLPC) (2G83-11)
4 Bottles (8.0 mL each) of AxSYM HIV Ag/Ab Combo Controls.
• The Negative Control, prepared in recalcified human
plasma, is nonreactive for HBsAg, HIV-1 RNA or HIV-1 Ag, anti-HCV,
and anti-HIV-1/HIV-2. Preservative: sodium azide.
• The HIV-1 Positive Control (PC1), prepared
in recalcified human plasma (inactivated), is reactive for anti-HIV-1
and nonreactive for HBsAg, HIV-1 RNA or HIV-1 Ag, and anti-HCV.
Preservative: sodium azide.
• The HIV-2 Positive Control (PC2), prepared
in recalcified human plasma (inactivated), is reactive for anti-HIV-2
and nonreactive for HBsAg, HIV-1 RNA or HIV-1 Ag, and anti-HCV.
Preservative: sodium azide.
• The Viral Lysate Positive Control (VLPC)
is purified HIV viral lysate prepared in TRIS buffer with stabilizers.
Preservative: sodium azide.
AxSYM HIV Ag/Ab Combo Controls: (NEG, PC1, VLPC) (2G83-12)
3 Bottles (8.0 mL each) of AxSYM HIV Ag/Ab Combo Controls.
• The Negative Control, prepared in recalcified human
plasma, is nonreactive for HBsAg, HIV-1 RNA or HIV-1 Ag, anti-HCV,
and anti-HIV-1/HIV-2. Preservative: sodium azide.
• The HIV-1 Positive Control (PC1), prepared
in recalcified human plasma (inactivated), is reactive for anti-HIV-1
and nonreactive for HBsAg, HIV-1 RNA or HIV-1 Ag, and anti-HCV.
Preservative: sodium azide.
• The Viral Lysate Positive Control (VLPC)
is purified HIV viral lysate prepared in TRIS buffer with stabilizers.
Preservative: sodium azide.
Control Range
Control Color Dye S/CO
Natural None 0.01 - 0.89
Blue Blue No. 9 1.00 - 10.00
Red Red No. 33 1.00 - 10.00
Red No. 33,
Purple Blue No. 9 1.00 - 10.00
AxSYM HIV Ag/Ab Combo Index Calibrator and Controls should be mixed
by gentle inversion prior to use.
OTHER REAGENTS
AxSYM Probe Cleaning Solution (9A35-05)
• 2 Bottles (220 mL each) AxSYM
Probe Cleaning Solution containing 2% tetraethylammonium hydroxide
(TEAH).
Solution 1 (MUP) (8A47-04)
• 4 Bottles (230 mL each) Solution 1 (MUP)
containing 4-Methylumbelliferyl Phosphate, 1.2 mM, in AMP buffer.
Preservative: sodium azide.
Solution 3 (Matrix Cell Wash) (8A81-04)
• 4 Bottles (1000 mL each)
Solution 3 (Matrix Cell Wash) containing 0.3 M sodium chloride in TRIS
buffer. Preservatives: sodium azide and antimicrobial agents.
Solution 4 (Line Diluent) (8A46)
• 1 Bottle (10 L) Solution 4 (Line Diluent)
containing 0.1 M phosphate buffer. Preservatives: sodium azide and
antimicrobial agent.
3
WARNINGS AND PRECAUTIONS
For In Vitro Diagnostic Use.
SAFETY PRECAUTIONS
CAUTION: This product contains human sourced infectious and/or
potentially infectious components. Refer to the REAGENTS section of
this package insert. HIV-1 Positive Control has been tested and found
to be reactive for anti-HIV-1. HIV-2 Positive Control has been tested and
found to be reactive for anti-HIV-2. Remaining components have been
tested and found to be nonreactive for antibodies to HCV, HIV-1/HIV-2 and
nonreactive for HBsAg and HIV-1 RNA or HIV-1 Ag. No known test method
can offer complete assurance that products derived from human sources
or inactivated microorganisms will not transmit infection. Therefore, it is
recommended that all human sourced materials be considered potentially
infectious and handled with appropriate biosafety practices.
• Some components of this product contain methylisothiazolones, which
are components of ProClin and are classified per applicable European
Community (EC) Directives as: Irritant (Xi). For a specific listing refer
to the REAGENTS section of this package insert. The following are
the appropriate Risk (R) and Safety (S) phrases.
R43 May cause sensitization by skin contact.
S24 Avoid contact with skin.
S35 This material and its container must be
disposed of in a safe way.
S37 Wear suitable gloves.
S46 If swallowed, seek medical advice immediately
and show this container or label.
• All components of this product contain sodium azide. Contact with
acids liberates very toxic gas. This material and its container must be
disposed of in a safe way.
• For product not classified as dangerous per European Directive
1999/45/EC as amended - Safety data sheet available for professional
user on request.
HANDLING PRECAUTIONS
• AxSYM HIV Ag/Ab Combo Reagents are susceptible to bubbles/
foaming and require inspection and removal of bubbles
before loading. Refer to the AxSYM System Operations Manual,
Section 9.
• Do not use Solution 1 (MUP) beyond the expiration date or a
maximum of 14 days on-board the AxSYM System. When loading
new Solution 1 (MUP), it is important to immediately tighten the
instrument cap for MUP to minimize exposure to air. Prolonged
exposure of MUP to air may compromise performance.
• Do not use reagent pack beyond the expiration date, or a maximum
of 336 cumulative hours on-board the AxSYM System.
• Do not mix reagents from different reagent packs. Do not mix reagents,
controls, and index calibrators from different lots. The reagent pack
and its associated index calibrator must be discarded together.
• Avoid microbial contamination of specimens and reagents. Use of
disposable pipettes or pipette tips is recommended.
• Avoid chemical contamination of reagents and equipment.
• Ensure that sufficient sample volume is present. If sample volume is
insufficient, the AxSYM System may indicate an error code and no
result will be reported. For a description of the system error codes,
refer to the AxSYM System Operations Manual, Section 10.
• Inadequate adherence to these package insert instructions may result
in inconsistent results.
• Use accurately calibrated equipment.
• Use caution in handling patient specimens to prevent cross
contamination.
Refer to the AxSYM System Operations Manual, Sections 7 and 8, for a
more detailed discussion of the safety and handling precautions during
system operation.
STORAGE INSTRUCTIONS
• The AxSYM HIV Ag/Ab Combo Reagent Pack, Index
Calibrator, and Controls must be stored upright at 2-8°C. The AxSYM
HIV Ag/Ab Combo Reagent Pack, Index Calibrator, and Controls may
be used immediately after removal from the refrigerator.
NOTE: The AxSYM HIV Ag/Ab Combo Reagent Kit is shipped on wet
ice and should be stored at 2-8°C after receipt.
 When stored and handled as directed, reagents are stable until Assay Parameters
expiration date. The AxSYM HIV Ag/Ab Combo Reagent Pack may be
on-board the AxSYM System for a maximum of 336 cumulative hours 70 Min correlation coefficient for low rates: 0.9700
(for example, 42 eight hour shifts). Recalibration may be required 71 Min correlation coefficient for high rates: 0.9700
to obtain maximum onboard reagent stability. More frequent use of 72 MUP T Delay-Time delay following MUP: 3.0500
controls may be required to monitor reagent performance within the 75 Low Extreme Value > 0.00
same lot. After 336 hours, the reagent pack and its associated index 76 High Extreme Value > 0.00
calibrator must be discarded. Refer to the AxSYM System Operations
Manual, Sections 2, 5, and Appendix C, for further information on 80 Interpretation Option to use > 1
tracking on-board time. 84 Hold results with POS interpretation > ON
Solution 1 (MUP) must be stored at 2-8°C (do not freeze). It may 85 Hold results with NEG interpretation > OFF
be used immediately after removing it from the refrigerator. It may 86 Hold results with GRY interpretation > ON
be on-board the AxSYM System for a maximum of 14 days. After 91 Low Range Undiluted: 0.00
14 days, it must be discarded. 92 High Range Undiluted: 80.00
** AxSYM HIV Ag/Ab Combo Assay File Version 1.00.1
• The AxSYM Probe Cleaning Solution, Solution 3 *** AxSYM HIV Ag/Ab Combo Assay File Version 1.00.2 or higher
(Matrix Cell Wash), and Solution 4 (Line Diluent) must be stored at NOTE: Parameters 43, 44, and 45 cannot be edited. There are no other
15-30°C. options for this assay.
INDICATIONS OF INSTABILITY OR DETERIORATION OF The AxSYM HIV Ag/Ab Combo values available for Assay Parameter 80
(Interpretation Option to use) are:
REAGENTS
When AxSYM HIV Ag/Ab Combo Controls, Negative Control, Positive POS Interp NEG Interp GRY Interp
Control 1, Positive Control 2, or Viral Lysate Positive Control values are 1. REACTIVE NEGATIVE GRAYZONE
out of the expected range, it may indicate deterioration of the reagents or 2. REACTIVE NEGATIVE NEGATIVE
errors in technique. Associated test results are invalid and the specimens
must be retested. Assay recalibration may be necessary. Refer to the To utilize the grayzone option, option 1 for parameter 80 (Interpretation
AxSYM System Operations Manual, Section 10, for further troubleshooting Option to use) must be selected. Specimens with assay S/CO values
information. equal to or greater than 0.90, and less than the cutoff are indicated as
“GRAYZONE” in the interpretation field. (Refer to INTERPRETATION OF
INSTRUMENT PROCEDURE RESULTS section.)
NOTE: AxSYM HIV Ag/Ab Combo must only be used with AxSYM System Refer to the AxSYM System Operations Manual for a detailed description
Software Version 3.60 or higher. of Instrument Procedures.
Assay File Installation
The AxSYM HIV Ag/Ab Combo Assay File Version 1.00.1 or higher must
SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS
be installed on the AxSYM System from the assay disk, 2G84-01 or • Human serum (collected in Kaolin-coated or serum separator tubes)
higher, prior to performing the AxSYM HIV Ag/Ab Combo assay. Refer to or plasma (collected in EDTA, sodium heparin, lithium heparin, sodium
the AxSYM System Operations Manual, Section 2, for proper installation citrate, ACD, CPD, CPD/Adsol, or CPDA-1) may be used in the AxSYM
procedures. HIV Ag/Ab Combo assay. Follow the manufacturer’s processing
instructions for serum and plasma collection tubes.
AxSYM HIV Ag/Ab Combo Assay Parameters
• The AxSYM System does not provide the capability to verify the
The default values for the assay parameters for the AxSYM HIV Ag/Ab sample type. It is the responsibility of the operator to verify that
Combo assay are listed below. Values for the assay parameters that the correct sample type(s) is (are) used in the AxSYM HIV Ag/Ab
can be edited contain a (>) symbol. These parameters can be displayed Combo assay.
and edited according to the procedure in the AxSYM System Operations
Manual, Section 2. In order to obtain values for the parameters with an • This assay was designed and validated for use with human serum
asterisk (*), review the specific Assay Parameters screen. Press PRINT or plasma from individual patient and donor specimens. Pooled
to print the assay parameters. specimens must not be used since the accurracy of their test results
has not been validated.
Assay Parameters • Gravity separation is not sufficient for specimen preparation.
1 Long Assay Name (English): HIV_Ag/Ab_Combo • All patient specimens to be tested in primary tubes must be centrifuged
6 Abbrev Assay Name (English): HIV_Ag_Ab to remove red blood cells or particulate matter. Follow the tube
11 Assay Number: 817 manufacturer’s instructions for centrifugation.
12 Assay Version: * • After specimens have been initially separated per the collection tube
13 Calibration Version: * manufacturer’s instructions, they must be clarified by centrifugation
at 150,000-300,000 g-minutes* if:
14 Assay File Revision: *
• they contain clots, red blood cells, or particulate matter
15 Assay Enabled > ON
• they require repeat testing, or
17 Assay Type: MEIA
• they have been frozen and thawed.
18 Standard Cal Reps > 3 Transfer clarified specimen to a sample cup or secondary tube for
43 Default Dilution Protocol > UNDILUTED testing.
44 Default Calibration Method > Index Cal * g-minute = relative centrifugal force (RCF) x minutes spun
45 Selected Result Concentration Units > S/CO The following chart lists examples of acceptable time and force ranges
46 Selected Result Decimal Places > 2 that meet this criteria.
64 Max Intercept-Max MUP intercept: 15000.0000 Time RCF x Time
65 Min Intercept-Min MUP intercept: 1850.0000 (minutes) RCF (x g) (g-minutes)
66 Upper Limit for NRMSE for low rates: 9999.9900 15 10000 150000
67 Upper Limit for NRMSE for high rates: 0.3900** or 20 7500 - 12000 150000 - 240000
0.5100***
25 6000 - 12000 150000 - 300000
68 Max Rate-Max rate used to check Min
NOTE: The AxSYM System offers an Auto Retest/Auto Dilution
MUP Intercept: 150.0000
feature. Due to the requirements discussed above, this feature
69 Min Rate-Rate cutoff for NRMSE and must not be used with this assay.
Corr. Coef.: 8.0000 • Centrifuged specimens with a lipid layer on top of the liquid must be
transferred to a sample cup or secondary tube. Care must be taken to
transfer only the clarified specimen and not the lipemic material.

4
• Specimens from heparinized patients may be incompletely coagulated AxSYM HIV Ag/Ab Combo PROCEDURE
and inconsistent results could occur due to the presence of fibrin. To Materials Provided
prevent partially coagulated specimens, draw the specimen prior to • 2G83-20 AxSYM HIV Ag/Ab Combo Reagent Kit containing:
heparin therapy or into a plasma collection tube.
AxSYM HIV Ag/Ab Combo
• Specimens may be stored on or off the clot or red blood cells for up
AxSYM HIV Ag/Ab Combo
to 7 days at 2-8°C prior to being tested.
100
• Specimens which are not tested within 7 days must be stored frozen
(-20°C or colder). Specimens must be removed from the clot or red 100
blood cells prior to freezing. Materials Required but Not Provided
• Multiple freeze/thaw cycles should be avoided although no qualitative • 2G83-11 AxSYM HIV Ag/Ab Combo Controls
differences were observed between the experimental controls and (NEG, PC1, PC2, VLPC):
the 36 nonreactive or 36 spiked reactive specimens subjected to
6 freeze/thaw cycles.
Mix by inverting thawed specimens 180 degrees from upright
and return, for a total of 10 inversion cycles. Visually inspect
the specimens for the absence of stratification. If layering or
stratification is observed, repeat until specimens are visibly
homogeneous.64 or
Centrifuge at 150,000 - 300,000 g-minutes prior to use to remove • 2G83-12 AxSYM HIV Ag/Ab Combo Controls
particulate matter and to ensure consistency in the results. (NEG, PC1, VLPC):
• When shipped, specimens must be packaged and labeled in
compliance with applicable state, federal, and international regulations
covering the transport of clinical specimens and infectious substances.
It is recommended to ship specimens off the clot or red blood cells
and frozen or refrigerated.
• 8A47-04
• All samples (patient specimens, controls, and calibrators) must be
• 8A81-04
tested within 3 hours of being placed on board the AxSYM System.
Refer to the AxSYM System Operations Manual, Section 5, for a more • 8A46
detailed discussion of on-board sample storage constraints. • 9A35-05 AxSYM
• Inspect all samples for bubbles. Remove bubbles prior to analysis. • 8A76-01
• For optimal results, specimens must be free of fibrin, red blood cells, • Pipettes and pipette tips (optional) to deliver the volumes specified
or other particulate matter. on the Orderlist screen.
• Do not use heat-inactivated specimens. CAUTION:
• Specimens with obvious microbial contamination should not be • AxSYM HIV Ag/Ab Combo Index Calibrator and Controls should be
used. mixed by gentle inversion prior to use.
• Performance has not been established using cadaver specimens or • When manually dispensing samples, verify that dispensing equipment
body fluids other than human serum or plasma. does not introduce cross contamination and that it delivers the specified
• No qualitative performance differences were observed between the sample volume. Use a separate pipette tip for each sample.
experimental controls and the 36 nonreactive or 36 spiked reactive • For optimal performance, it is important to follow the routine
specimens tested with elevated levels of bilirubin (≤ 20 mg/dL), maintenance procedures defined in the AxSYM System Operations
hemoglobin (≤ 500 mg/dL), total protein (≤ 12 g/dL), or red blood Manual, Section 9. If your laboratory requires more frequent
cells (≤ 0.4% v/v). maintenance, follow those procedures.
• No qualitative performance differences were observed between the Assay Procedure
experimental controls and the 35 nonreactive or 35 spiked reactive CAUTION: The System status must be WARMING, PAUSED, READY, or
specimens tested with elevated levels of lipids (≤ 3000 mg/dL). STOPPED before adding or removing sample segments, reagent packs,
SAMPLE VOLUME or reaction vessels.
The sample volume required to perform a single AxSYM HIV Ag/Ab Combo NOTE: The AxSYM System Auto Retest/Auto Dilution feature must not
test on the AxSYM System varies according to the type of sample container be used for this assay. Refer to the SPECIMEN COLLECTION AND
used. For sample cups the minimum (STAT and ROUTINE) sample volume PREPARATION FOR ANALYSIS section of this package insert.
required is 194 μL. For every additional AxSYM HIV Ag/Ab Combo test 1. Check for sufficient onboard inventory of Matrix Cells, bulk solutions,
performed from the same sample container, an additional 144 μL of and sample segment availability.
sample is required. 2. Check for sufficient waste collection capacity.
The sample cup minimum volumes for both STAT and ROUTINE tests are
calculated by the AxSYM System. They are displayed on the Orderlist
CAUTION:
screen at the time the test(s) is(are) ordered and printed in the Orderlist • Do not open the Interior Waste Door or the AxSYM Processing Center
Report. When using Host Order Query, the Orderlist screen information and Cover while any test is in progress. If opened, all processing will stop.
Orderlist Report are not available. Refer to the AxSYM System Operations All tests will be terminated and must be repeated.
Manual, Section 5, for a description of the Host Order Query option. • The cap for reagent bottle 4 must be manually opened prior to running
To obtain the recommended volume requirements for the AxSYM HIV Ag/Ab an AxSYM HIV Ag/Ab Combo assay. Upon completion of the run, close
Combo Index Calibrator and Controls, hold the bottles vertically and the reagent bottle 4 cap securely.
dispense 10 drops of Index Calibrator or 8 drops of Negative or Positive 3. Order the AxSYM HIV Ag/Ab Combo Index Calibrator, AxSYM HIV
Controls into each respective sample cup. Ag/Ab Combo Controls, and/or patient specimens as required.
For sample volume requirements in primary or aliquot tubes, and control Assign or modify sample segment position (S/P) for each sample, as
volume requirements for multiple AxSYM HIV Ag/Ab Combo reagent lots, necessary. Refer to the QUALITY CONTROL PROCEDURES section
refer to the AxSYM System Operations Manual, Section 5. in this package insert for calibration and control requirements.
Index Calibration
Perform AxSYM HIV Ag/Ab Combo calibration by testing three
replicates of the Index Calibrator. Invert gently to mix and dispense
at least 10 drops of the Index Calibrator into a sample cup. Do not
simultaneously calibrate more than one AxSYM HIV Ag/Ab Combo
reagent lot.

5
 Controls
Perform quality control by testing Positive and Negative Controls (one
test each). Invert gently to mix and dispense at least 8* drops each
of the Positive and Negative Controls into individual sample cups.
* When more than one AxSYM HIV Ag/Ab Combo reagent lot is
on board the AxSYM System, multiply the control volume by the
number of lots.
Patient Specimens
Ensure that sufficient volume is present in the sample cups or tubes.
The sample cup minimum volume is 194 μL for the first AxSYM HIV Ag/Ab
Combo test plus 144 μL for each additional AxSYM HIV Ag/Ab Combo
test. For volume requirements in primary or aliquot tubes, refer to the
AxSYM System Operations Manual, Section 5.
NOTE: The operator may obtain an Orderlist Report by pressing PRINT.
The printout contains sample placement information and minimum STAT
sample cup volume requirements for all tests ordered. When using the
Host Order Query, the Orderlist Report is not available. Refer to the
AxSYM System Operations Manual, Section 5, for a description of the
Host Query option.
4. Place sample segments containing the ordered samples into the
sample carousel.
5. Open reagent bottle 4. Place the AxSYM HIV Ag/Ab Combo Reagent
Pack into the reagent pack carousel.
6. Ensure that reaction vessels (RVs) are present on the RV Carousel.
Additional RVs may be added as needed.
7. Press RUN. All entries on the Order screen are transferred to the
Order Status screen for sample processing.
8. Review the results to determine whether retesting is required.
9. When testing is completed, close reagent bottle 4 and remove the
samples and the AxSYM HIV Ag/Ab Combo Reagent Pack from the
sampling center. Store at 2-8°C.
NOTE: When using the onboard tracking feature, the operator must perform
a reagent pack scan after removing any pack from the system in order to
maintain the validity of the reagent pack stability time.
Refer to Sections 5 and 6 of the AxSYM System Operations Manual for a
detailed explanation of performing assay calibration and sample testing
procedures.
QUALITY CONTROL PROCEDURES
CALIBRATION
A minimum of three replicates of the AxSYM HIV Ag/Ab Combo Index
Calibrator must be tested for an AxSYM HIV Ag/Ab Combo calibration. A
single sample of both the Positive and Negative Controls must be tested
as a means of evaluating the calibrated equipment.
NOTE: It is recommended that all three AxSYM HIV Ag/Ab Combo Positive
Controls, Positive Control 1, Positive Control 2, and Viral Lysate Positive
Control, be run to verify the calibration.
If the AxSYM HIV Ag/Ab Combo assay is used to evaluate HIV-2, the HIV-2
Positive Control must be tested every 24 hours.
Once the AxSYM HIV Ag/Ab Combo calibration is accepted and stored,
all subsequent samples may be tested without further calibration unless
one or more of the following occur:
• A reagent pack with a new lot number is used.
• Any of the AxSYM HIV Ag/Ab Combo Control values is out of its
specified range.
• The MEIA Optics Verification Update has been performed.
Refer to the AxSYM System Operations Manual, Section 6, for additional
information.
The operator must verify that the AxSYM HIV Ag/Ab Combo Control values
are within the acceptable ranges specified in this package insert. Refer to
the REAGENTS section for AxSYM HIV Ag/Ab Combo control ranges.
The AxSYM System verifies that the results of an assay calibration meet
the specifications assigned to selected validity parameters. An error
message occurs when the calibration fails to meet a specification. Refer
to the AxSYM System Operations Manual, Section 10, for an explanation
of the corrective actions for the error code. Refer to the AxSYM System
Operations Manual, Appendix E, for an explanation of the calibration validity
parameters that may be used by the AxSYM System.
6
QUALITY CONTROL
The minimum control requirement for an AxSYM HIV Ag/Ab Combo assay
is a single sample of the Positive and Negative Controls tested every
24 hours, each day of use for each reagent lot. Controls may be placed
in any position in the sample carousel.
NOTE: It is recommended that all three AxSYM HIV Ag/Ab Combo Positive
Controls, Positive Control 1, Positive Control 2, and Viral Lysate Positive
Control, be run to verify the calibration.
If the AxSYM HIV Ag/Ab Combo assay is used to evaluate HIV-2, the HIV-2
Positive Control must be tested every 24 hours.
If the quality control procedures in your laboratory require more frequent
use of controls to verify test results, follow those procedures.
The AxSYM HIV Ag/Ab Combo Control values must be within the acceptable
ranges specified in this package insert (see REAGENTS section). If a
control value is out of its specified range, the associated test results are
invalid and must be retested. Recalibration may be indicated.
The AxSYM System has the capability to generate a Levey-Jennings plot
of each assay’s quality control performance. Refer to the AxSYM System
Operations Manual, Section 5. At the discretion of the laboratory, selected
quality control rules may be applied to the quality control data.
FLUORESCENCE BACKGROUND ACCEPTANCE CRITERIA
Quality control with regard to the MUP substrate blank is automatically
determined by the instrument and checked under Assay Parameter 64
(Max Intercept-Max MUP intercept) each time a test result is calculated.
If the MUP intercept value is greater than the maximum allowable value,
the result is invalid. The test request will be moved to the Exceptions List
where it will appear with the message “1064 Invalid test result, intercept
too high” and the calculated intercept value. Refer to the AxSYM System
Operations Manual, Section 10, when this error message is obtained.
Refer to the AxSYM System Operations Manual, Section 2, for further
information on parameter files.
RESULTS
CALCULATION
The AxSYM HIV Ag/Ab Combo assay protocol calculates the cutoff rate
(CO) from the mean rate of three Index Calibrator replicates and stores
the result. The cutoff rate is determined by adding 27.5 to the mean Index
Calibrator rate.
Cutoff rate (CO) = Index Calibrator mean rate + 27.5
The AxSYM HIV Ag/Ab Combo assay protocol calculates a result based
on the ratio of the sample rate (S) to the cutoff rate for each sample
and control.
S/CO = sample rate/cutoff rate
FLAGS
Some results may contain information in the Flags field. For a description
of the flags that may appear in this field, refer to the AxSYM System
Operations Manual, Sections 1 and 2.
INTERPRETATION OF RESULTS
Initial AxSYM HIV Ag/Ab Combo Results
Initial Result Retest
(S/CO) Instrument Flag Interpretation Procedure
≥ 1.00 REACTIVE Reactive Retest in duplicate
0.90 to < 1.00 GRAYZONE Grayzone Reactive Retest in duplicate
< 0.90* NEGATIVE Negative No retest required
* If parameter 80-option 2 is selected, NEGATIVE is designated as
< 1.00 S/CO.
NOTE: Specimens that are reactive or grayzone on initial testing must
be centrifuged according to directions in the SPECIMEN COLLECTION
AND PREPARATION FOR ANALYSIS section of this package insert and
retested in duplicate.
 Final AxSYM HIV Ag/Ab Combo Results EXPECTED VALUES
Initial Result Retest Results Final Result Interpretation In a random population of 7900 volunteer blood donor specimens,
10 (0.13%) were repeatedly reactive by AxSYM HIV Ag/Ab Combo. Among
Reactive/ Both of the Negative HIV-1/HIV-2 792 specimens from individuals with HIV-1 classified disease status, HIV-1
Grayzone duplicate retests antibodies and/or unknown disease status, HIV-1 subtyped, and unknown disease status
are negative. HIV p24 antigen for HIV-1 group O, HIV-1 p24 antigen, and HIV-2, the AxSYM HIV Ag/Ab
not detected. Combo assay detected 100.00% as reactive.
One or both of Reactive or Presumptive
the duplicate Grayzone evidence of SPECIFIC PERFORMANCE CHARACTERISTICS
retests are HIV-1/HIV-2 PRECISION
reactive antibodies and/or Assay reproducibility was determined during the clinical evaluation of
or grayzone. HIV p24 antigen; AxSYM HIV Ag/Ab Combo. A six-member panel and assay controls were run
a supplemental at 10 sites on 10 instruments in total, with the exception of the HIV-1 p24
assay should be panel which was tested at eight sites only. Nine sites tested two different
performed. clinical lots of the controls and one site tested three different clinical lots of
Nonreactive No retest required. Negative HIV-1/HIV-2 the controls. All samples were tested in triplicate in three runs. At one site,
antibodies and/or the panel and assay controls were tested on one clinical lot; at eight sites,
HIV p24 antigen they were tested on each of two clinical lots; and at one site, they were
not detected. tested across four different clinical lots. The intra-assay and inter-assay
standard deviation (SD) and percent coefficient of variation (%CV) were
• If repeat testing shows the assay S/CO value for both retests to be analyzed with a variance components analysis 65 using a mixed analysis
less than 0.90, the specimen is classified as negative. of variance model 66 (Table 1).
• If either duplicate retest S/CO value is greater than or equal to 0.90,
the specimen should be tested by supplemental tests. Analysis of Table 1
follow up samples is recommended. Reproducibility of AxSYM HIV Ag/Ab Combo
• Interpretation of results of specimens with a final result of reactive Total Mean Intra-assay Inter-assay
or grayzone by AxSYM HIV Ag/Ab Combo and indeterminate by Sample (N) (S/CO) SD %CV SD %CV
supplemental testing is unclear; further clarification may be obtained Undiluted 189 25.96 1.29 5.0 2.41 9.3
by testing another specimen taken three to six weeks later. anti-HIV-1
• AxSYM HIV Ag/Ab Combo and supplemental assay results should Undiluted 189 54.15 2.00 3.7 2.47 4.6
be interpreted in conjunction with the patient’s clinical presentation, anti-HIV-2
history, and other laboratory results. Diluted HIV-1 189 11.85 0.54 4.6 0.74 6.3
LIMITATIONS OF THE PROCEDURE medium
• It is recognized that this method for the detection of HIV p24 antigen Diluted HIV-2 189 11.79 0.52 4.4 0.91 7.7
and/or antibodies to HIV-1/HIV-2 may not detect all infected individuals. medium
A negative test result does not exclude the possibility of exposure to Anti-HIV-1 189 3.92 0.28 7.2 0.33 8.5
or infection with HIV-1/HIV-2. group O
• The AxSYM HIV Ag/Ab Combo assay does not discriminate between HIV-1 p24 162 1.59 0.07 4.2 0.10 6.4
HIV-1/HIV-2 antibodies and/or HIV p24 antigen reactivity.
Negative 414 0.38 0.02 4.5 0.02 5.5
• The presence of HIV-1/HIV-2 antibodies and/or HIV p24 antigen is
Control
not a diagnosis of AIDS. It is recommended that repeatedly reactive
specimens be investigated by supplemental testing. Individuals who Positive 414 3.84 0.21 5.3 0.25 6.6
are repeatedly reactive should be referred for medical evaluation Control 1
which may include additional testing. Positive 414 3.55 0.17 4.7 0.22 6.2
• This assay was designed and validated for use with human serum or Control 2
plasma from individual patient specimens. Data are not available to Viral Lysate 414 3.23 0.16 4.9 0.19 5.9
interpret tests performed on pooled blood. Pooled specimens must Positive
not be used. Control
• Centrifuged specimens with a lipid layer on the top of the liquid must Representative performance data are shown. Results obtained at individual
be transferred to a sample cup or secondary tube. Care must be taken laboratories may vary.
to transfer only the clarified specimen and not the lipemic material. SPECIFICITY
• Thawed specimens must be mixed by inverting 180 degrees from Specificity is based on testing of random blood donors and hospitalized
upright and return, for a total of 10 inversion cycles. Visually patient populations (serum and plasma specimens).
inspect the specimens for the absence of stratification. If layering
or stratification is observed, repeat until specimens are visibly Specificity is defined as the ability of the AxSYM HIV Ag/Ab Combo assay
homogeneous.64 to detect randomly selected specimens as negative in populations at low
risk for infection.
• Specimens containing red blood cells or particulate matter must be
clarified by centrifugation prior to testing. Refer to the SPECIMEN • Specificity based on zero prevalence of antibodies to HIV-1 or HIV-2,
COLLECTION AND PREPARATION FOR ANALYSIS section in this and/or HIV-1 p24 antigen in random blood donors (7900 tested) is
package insert. estimated to be 99.87% (7890/7900) for the AxSYM HIV Ag/Ab Combo
assay (Table 2).
• Performance has not been established using cadaver samples, or
body fluids such as urine, saliva, semen, or amniotic fluid. • Specificity based on low prevalence of antibodies to HIV-1 or HIV-2,
and/or HIV-1 p24 antigen in a hospitalized population (1938 tested)
• The AxSYM System “Automatic Sample Retest” feature must not is estimated to be 99.90% (1929/1931) for the AxSYM HIV Ag/Ab
be used due to the AxSYM HIV Ag/Ab Combo assay requirement to Combo assay (Table 2).
centrifuge all specimens prior to retesting.
The data from 7900 random blood donors from seven geographically
• Specimens from heparinized patients may be incompletely coagulated distinct regions and 1938 hospitalized patients from six geographically
and inconsistent results could occur due to the presence of fibrin. To distinct regions are summarized in Table 2. The specificity of the assay
prevent partially coagulated specimens, draw the specimen prior to was calculated as follows:
heparin treatment or into a plasma collection tube.
• Specimens containing red blood cells (0.4% v/v or greater, which are True negative specimens
x 100 = % Specificity
visibly red) may give inconsistent results with the AxSYM HIV Ag/Ab (True negative specimens +
Combo assay, and therefore must be centrifuged prior to testing. False positive specimens)

7
 Table 2 SENSITIVITY
Specificity Results Using Random Blood Donors The sensitivity for anti-HIV-1 (including anti-HIV-1 group O), HIV-1 p24
and Hospitalized Patients antigen, and anti-HIV-2 is expressed in terms of detection rate using
confirmatory assay results (e.g., Western blot, HIV-1 p24 antigen,
Non-Confirmed HIV-1 PCR) as a basis for comparison.
Specimens Initially Repeatedly
The ability of AxSYM HIV Ag/Ab Combo to detect antibodies to HIV-1/HIV-2
Population Tested Reactive Reactive
and/or HIV-1 p24 antigen in individuals clinically diagnosed with HIV-1
Group (Site) (N) (N) (%) (N) (%) infection and classified disease status or from seropositive individuals
Blood Donors (Total) 7900 8 0.10 10a 0.13 (unknown disease status) is shown in Table 5.
Hospitalized • The HIV-1 antibody detection rate in a population of 615 HIV-1
1938 11 0.57 2b 0.10
Patients (5 sites) antibody confirmed seropositive individuals is 100% (615/615). This
a Two initial grayzone specimens were repeatedly reactive upon retest. rate includes 453 clinically diagnosed patients from different disease
Four of the 10 non-confirmed repeatedly reactive specimens were stages of HIV-1 infection and 55 HIV-1 subtyped samples.
indeterminate by HIV-1 or HIV-2 Western blot. None of the specimens • The HIV-2 antibody detection rate in a population of 108 HIV-2 antibody
could be confirmed by HIV-1/ HIV-2 Western blot, HIV-1 p24 antigen, confirmed seropositive individuals is 100% (108/108).
and/or HIV-1 PCR. • The HIV-1 p24 antigen detection rate in a defined (≥ 25 pg/mL)
b Six samples, which were initially and repeatedly reactive, could be population of 50 HIV-1 p24 antigen confirmed positive individuals is
confirmed by HIV-1 Western blot. One sample, which was initially and 100% (50/50).
repeatedly reactive, could be confirmed by HIV-1 PCR. • The HIV-1 group O antibody detection rate in a population of 19 HIV-1
Representative performance data are shown. Results obtained at individual group O antibody confirmed positive specimens tested is 100%
laboratories may vary. (19/19).
AxSYM HIV Ag/Ab Combo was used to test 319 specimens containing Table 5
potentially interfering substances. Results are shown in Table 3. This Detection of Anti-HIV-1 (Groups M and O), Anti-HIV-2 and/or
group contained specimens from the following categories: (viral infection) HIV-1 p24 Antigen in Serum or Plasma Specimens from Patients with
CMV, EBV, HSV, HAV, HBV, anti-HCV, anti-HTLV-I, anti-HTLV-II, rubella; Classified Disease Status and from Seropositive Individuals
(bacterial/other) fungal infection/anti-yeast (e.g., Candida albicans), Specimens
toxoplasmosis, syphilis, E. coli; (autoimmune) rheumatoid factor (RF), HIV Tested Reactive
autoimmune antibodies (ANA); (other conditions) pregnant females all
Group Infection (N) (N) (%)
trimesters, multiparous females, elevated IgG, elevated IgM, multiple
myeloma, monoclonal gammopathy, flu vaccine recipients, and human Classified Disease HIV-1 453a 453 100
antimouse antibodies (HAMA). Status
Unknown Disease HIV-1 107 107 100
Table 3 Status
Plasma Specimens Containing Potentially Interfering Substances
Subtyped HIV-1 55b 55 100
Non-Confirmed
Specimens Repeatedly Repeatedly Unknown Disease HIV-1 Group O 19c 19 100
Tested Reactive Reactive Status
Group (N) (N) (%) (N) (%) HIV-1 p24 Ag 50 50 100
Potentially Interfering HIV-2 108 108 100
319 5a,b 1.57 4 1.26
Substances Total HIV-Positive HIV-1 / HIV-2 / 792 792 100
a Four samples, which were initially and repeatedly reactive, could HIV-1 p24 Agd
not be confirmed by HIV-1/ HIV-2 Western blot, HIV-1 p24 antigen, a Specimens drawn from individuals in CDC classifications Stage A,
and/or HIV-1 PCR. These samples belong to the following categories: Stage B, or Stage C.
E. coli (2), RF (1), monoclonal gammopathy (1). E. coli infections were
b HIV-1 specimen subtypes: subtype A (11), subtype B (3), subtype
detected in urine samples.
B/D (1), subtype C (7), subtype D (5), subtype E (6), subtype F (3),
b One sample, which was initially and repeatedly reactive, could be subtype F1 (13), subtype G (5), subtype J (1).
confirmed by HIV-1 Western blot. This sample belongs to the following
c Nine of the HIV-1 group O specimens were diluted 1:100, while the
sample category: monoclonal gammopathy.
remaining 10 specimens were undiluted.
Representative performance data are shown. Results obtained at individual
d All specimens were sourced from different geographical regions:
laboratories may vary.
Argentina, China, Ghana, Ivory Coast, Mozambique, Thailand, Uganda,
AxSYM HIV Ag/Ab Combo was used to test specimens from individuals USA, Zimbabwe, Belgium, Cameroon, Germany, Iran, Italy, Kenya,
presumed to have an increased risk for blood transmissible infections. Korea, Netherlands, Nigeria, Poland, Spain, Syria, Togo, Turkey, Zaire,
Results are shown in Table 4. This group contains specimens from the Romania, Arabia, Brazil, Ethiopia, France, Great Britain, Lebanon, and
following categories: hemodialysis, hemophiliacs, multiple transfusion Russia.
recipient, homosexual males, intraveneous drug users (IVDU), and sexually
Representative performance data are shown. Results obtained at individual
transmitted diseases (STD).
laboratories may vary.
Table 4 Sensitivity of the assay to detect antibodies to HIV-1 and/or HIV-2 was
Increased Risk Population evaluated in sequential specimens from 22 seroconverting donors. These
Non-Confirmed well-characterized specimens are commercially available from Boston
Specimens Repeatedly Repeatedly Biomedica (BBI, Massachusetts, USA), North American Biologicals Inc.
Tested Reactive Reactive (Nabi, USA), Pyramid (USA) or Bioclinical Partners (BCP, Massachusetts,
Group (N) (N) (%) (N) (%) USA). The sensitivity of the assay in seroconverting donors is better than
High Risk 179 42a 23.5 0 0 the methods of comparison. The AxSYM HIV Ag/Ab Combo assay was
reactive 1-2 bleeds earlier than the method of comparison for 16 out of
a 42 specimens were confirmed by HIV-1 Western blot. These samples 22 seroconversion panels and equal in 4 out of 22 seroconversion
belong to the following categories: homosexual males (29), STD (5), panels. Two seroconversion panels were not detected by the method of
hemophiliacs (6), and multiple transfusion (2). comparison. Table 6 shows a subset of six representative seroconversion
Representative performance data are shown. Results obtained at individual panels.
laboratories may vary.

8
 Table 6 Table 7
Results for Seroconverting Donors (S/CO) Analytical Sensitivity on AFSSAPS Panel
AxSYM AxSYM HIV-1 p24
HIV Ag/Ab HIV 1/2 Antigen
Day of Combo gO Sample ID (pg/mL) Lot 1 Lot 2 Lot 3
Dona- (LN 2G83) (LN 3D41) Western HIV-1 p24 S2023 500 14.85 16.70 14.54
Donor tion Result Result Blota Antigena PCRa S2024 250 8.95 9.43 7.00
BBI 0 0.42 0.49 Neg 0.4 Neg S2025 100 3.91 4.15 3.22
PRB923 7 0.41 0.48 Neg 0.4 Neg S2026 50 2.23 2.30 1.64
12 0.39 0.41 Neg 0.5 Neg S2027 25 1.35 1.45 1.16
14 0.36 0.43 Neg 0.4 Neg S2028 10 0.73 0.79 0.71
28 0.40 0.44 Neg 0.4 Neg S2029 5 0.55 0.65 0.57
30 0.38 0.49 Neg 0.4 Neg Analytical sensitivity
35 0.42 0.51 Neg 0.4 Pos 16.7 14.5 21.2
(pg/mL)
37 1.45 0.45 Neg 1.0 Pos Representative performance data are shown. Results obtained at individual
47 49.01 1.28 Neg >23.3 Pos laboratories may vary.
84 6.12 8.59 Ind 0.4 Pos
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