en

HIV Ag/Ab Combo

system 4J27
B4J2S0
G4-2947/R04
Read Highlighted Changes
Revised July 2013

HIV Ag/Ab Combo

Customer Service: Contact your local representative or find country-specific contact information
on www.abbottdiagnostics.com
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 Control Number

In Vitro Diagnostic Medical Reagent Lot

Device
Reaction Vessels
Lot Number
Sample Cups
Serial Number
Septum

Expiration Date Replacement Caps

Contains sodium azide.

Store at 2-8°C Contact with acids
liberates very toxic gas.
Global Trade Item
Consult instructions for use Number
Product of Germany

Manufacturer Warning: Severe Irritant

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

component naming.

1
NAME BIOLOGICAL PRINCIPLES OF THE PROCEDURE
ARCHITECT HIV Ag/Ab Combo The ARCHITECT HIV Ag/Ab Combo assay is a two-step immunoassay to
determine the presence of HIV p24 antigen and antibodies to HIV‑1 (Group
INTENDED USE M and Group O) and HIV-2 in human serum and plasma using CMIA
The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent technology with flexible assay protocols, referred to as Chemiflex.
microparticle immunoassay (CMIA) for the simultaneous qualitative
detection of HIV p24 antigen and antibodies to human immunodeficiency In the first step, sample, ARCHITECT i Wash Buffer, assay diluent, and
virus type 1 and/or type 2 (HIV-1/HIV-2) in human serum or plasma paramagnetic microparticles are combined. HIV p24 antigen and HIV-1/HIV-2
including specimens collected post-mortem (non-heart-beating). The antibodies present in the sample bind to the HIV-1/HIV-2 antigen and HIV p24
ARCHITECT HIV Ag/Ab Combo assay is intended to be used as an aid in monoclonal (mouse) antibody coated microparticles. After washing, the
the diagnosis of HIV-1/HIV-2 infection and as a screening test to prevent HIV p24 antigen and HIV-1/HIV-2 antibodies bind to the acridinium-labeled
transmission of HIV‑1/ HIV-2 to recipients of blood, blood components, conjugates (HIV‑1/HIV-2 antigens [recombinant], synthetic peptides, and
cells, tissue and organs. An ARCHITECT HIV Ag/Ab Combo result does HIV p24 antibody [mouse, monoclonal]). Following another wash cycle,
not distinguish between the detection of HIV p24 antigen, HIV‑1 antibody, pre‑trigger and trigger solutions are added to the reaction mixture. The
or HIV-2 antibody reactivity. resulting chemiluminescent reaction is measured as relative light units (RLUs).
A direct relationship exists between the amount of HIV antigen and antibodies
SUMMARY AND EXPLANATION OF TEST in the sample and the RLUs detected by the ARCHITECT i System optics.
Acquired immunodeficiency syndrome (AIDS) is caused by two types of The presence or absence of HIV p24 antigen or HIV‑1/HIV-2 antibodies
human immunodeficiency viruses, collectively designated HIV.1-7 in the specimen is determined by comparing the chemiluminescent
HIV is the etiologic agent of AIDS.1,3,6,7 HIV is transmitted by sexual contact, signal in the reaction to the cutoff signal determined from an ARCHITECT
exposure to blood or blood products, and prenatal infection of a fetus or HIV Ag/Ab Combo calibration. Specimens with signal to cutoff (S/CO) values
perinatal infection of a newborn.8 Antibodies against HIV are nearly always greater than or equal to 1.00 are considered reactive for HIV p24 antigen
detected in AIDS patients and HIV infected asymptomatic individuals,8,9 and or HIV-1/HIV-2 antibodies. Specimens with S/CO values less than 1.00 are
HIV infection is always detected in AIDS patients and seropositive individuals considered nonreactive for HIV p24 antigen or HIV-1/HIV-2 antibodies.
by culture or amplification of viral RNA and/or proviral DNA.8,10 Specimens that are initially reactive in the ARCHITECT HIV Ag/Ab Combo
Phylogenetic analysis classifies HIV-1 into groups M (major), N (non-M, assay should be retested in duplicate. Repeat reactivity is highly predictive
non-O), and O (outlier).4,5 Group M viruses have spread throughout the of the presence of HIV p24 antigen and HIV-1/HIV-2 antibodies. However,
world to cause the global AIDS pandemic. In contrast, groups N and O are as with all immunoassays, the ARCHITECT HIV Ag/Ab Combo assay may
relatively rare and endemic to west central Africa.11-17 However, group O yield nonspecific reactions due to other causes, particularly when testing
infections have been identified in Europe and the USA.18-22 HIV-1 group M in low prevalence populations. A repeatedly reactive specimen should be
is composed of genetic subtypes (A, B, C, D, F, G, H, J, and K) and investigated further with sensitive, supplemental HIV-specific tests, such
circulating recombinant forms (CRFs).5,23 The geographic distribution and as immunoblots, antigen tests, and HIV nucleic acid tests. Supplemental
regional predominance of HIV-1 subtypes and CRFs vary. All subtypes and testing of repeat-reactive specimens obtained from individuals at risk
many recombinant strains exist in Africa with CRF02_AG the predominant for HIV infection usually confirms the presence of HIV antibodies or HIV
strain in west and west central Africa, subtypes A, C, and D predominant antigen, and HIV nucleic acid. A full differential diagnostic work-up for the
in east central Africa, and subtype C predominant in southern Africa.23-28 diagnosis of AIDS and AIDS-related conditions includes an examination of
HIV-1 subtype B is the predominant subtype in the USA, Europe, Japan, the patient’s immune status and a clinical history.
and Australia. However, a significant percentage of new HIV-1 infections For additional information on system and assay technology, refer to the
in Europe are caused by non-B subtypes.29,30 In Asia, subtype C is found ARCHITECT System Operations Manual, Section 3.
in India, and CRF01_AE (formerly called subtype E) and subtype B are in
REAGENTS
Thailand and southeast Asia.31 South America predominantly has subtypes
B and F.32,33 Reagent Kit, 100 Tests, 4 x 100 Tests, 4 x 500 Tests
Note: Some kit sizes are not available in all countries or for use on all
Human immunodeficiency virus type 2 (HIV-2) is similar to HIV-1 in
ARCHITECT i Systems. Please contact your local distributor.
its structural morphology, genomic organization, cell tropism, in vitro
cytopathogenicity, transmission routes, and ability to cause AIDS. 6-8 ARCHITECT HIV Ag/Ab Combo Reagent Kit (4J27)
However, HIV-2 is less pathogenic than HIV-1, and HIV-2 infections have • 1 or 4 Bottle(s) (6.6 mL per 100 test bottle/27.0 mL
a longer latency period with slower progression to disease, lower viral per 500 test bottle) Microparticles: HIV-1/HIV-2 antigen (recombinant)
titers, and lower rates of vertical and horizontal transmission.34-37 HIV-2 is and HIV p24 antibody (mouse, monoclonal) coated microparticles
endemic to west Africa but HIV-2 infections, at a low frequency compared in TRIS buffered saline. Minimum concentration: 0.07% solids.
to HIV-1, have been identified in the USA, Europe, Asia, and other regions Preservative: Sodium Azide.
of Africa.31,37 HIV-2 is classified into genetic subtypes A-G with most • 1 or 4 Bottle(s) (5.9 mL per 100 test bottle/26.3 mL
infections caused by subtypes A and B.38,39 per 500 test bottle) Conjugate: Acridinium-labeled HIV-1 antigens
The key immunogenic protein and antigenic target for serodetection of (recombinant), acridinium-labeled HIV-1/HIV-2 synthetic peptides, and
HIV infection is the viral (HIV) transmembrane protein (TMP). Antibodies acridinium-labeled HIV p24 antibody (mouse, monoclonal) conjugates
against the TMP (anti-TMP) consistently are among the first to appear at in phosphate buffer with protein (bovine) and surfactant stabilizers.
seroconversion of HIV infected individuals.9,40-44 The anti-TMP response Minimum concentration: 0.05 µg/mL. Preservative: Sodium Azide.
remains relatively strong throughout the course of the disease, as • 1 or 4 Bottle(s) (5.9 mL per 100 test bottle/26.3 mL
evidenced by the near universal presence of antibodies against the TMP per 500 test bottle) Assay Diluent: HIV Ag/Ab Combo assay diluent
in asymptomatic and symptomatic stages of HIV infection.9,40-44 TMPs from containing TRIS buffer. Preservative: Sodium Azide.
HIV-1 groups M and O and HIV-2 are represented in ARCHITECT HIV Ag/Ab
Other Reagents
Combo reagents by five recombinant antigens and two synthetic peptides
ARCHITECT i Pre-Trigger Solution
derived from native TMP sequences. The rationale for including three pairs
of TMPs is derived from the genetic diversity within HIV-1 and between • Pre-Trigger Solution containing 1.32% (w/v)
HIV-1 and HIV-2.4,5,45,46 Serologic studies indicate that although HIV-1 and hydrogen peroxide.
HIV-2 share multiple common epitopes in their core antigens, the envelope ARCHITECT i Trigger Solution
glycoproteins are much less cross-reactive.7,47-51 Antibodies elicited against • Trigger Solution containing 0.35 N sodium
the TMP (or portions of the TMP) of a viral strain within one group or type hydroxide.
may react well, poorly, or not at all with the TMP (or portions of the TMP) ARCHITECT i Wash Buffer
from a viral strain of a different group or type.15,52-57 An exception may be • Wash Buffer containing phosphate buffered saline
antibodies elicited against HIV-1 group N.11,12 solution. Preservatives: Antimicrobial Agents.
Early after infection with HIV, but prior to seroconversion, HIV antigen(s)
may be detected in serum or plasma specimens.57-65 The HIV structural
protein most often used as the marker of antigenemia is the core protein,
p24. The ARCHITECT HIV Ag/Ab Combo uses anti-HIV p24 in the reagents
to detect HIV p24 antigen prior to seroconversion, thereby decreasing the
seroconversion window and improving early detection of HIV infection.

2
WARNINGS AND PRECAUTIONS • When stored and handled as directed, reagents are stable until the
• expiration date.
• For In Vitro Diagnostic Use • Reagents may be stored on or off the ARCHITECT i System. If reagents
Package insert instructions must be carefully followed. Reliability of are removed from the system, store them at 2-8°C (with septums and
assay results cannot be guaranteed if there are any deviations from the replacement caps) in an upright position. For reagents stored off the
instructions in this package insert. system, it is recommended that they be stored in their original trays and
boxes to ensure they remain upright. If the microparticle bottle does
Safety Precautions not remain upright (with a septum installed) while in refrigerated
• CAUTION: This product requires the handling of human specimens. storage off the system, the reagent kit must be discarded. For
It is recommended that all human sourced materials are considered information on unloading reagents, refer to the ARCHITECT System
potentially infectious and be handled in accordance with the OSHA Operations Manual, Section 5.
Standard on Bloodborne Pathogens. 66 Biosafety Level 2 67 or other
appropriate biosafety practices 68,69 should be used for materials that Indications of Reagent Deterioration
contain or are suspected of containing infectious agents. When a control value is out of the specified range, it may indicate
deterioration of the reagents or errors in technique. Associated test results
The following warnings and precautions apply to this component:
are invalid and samples must be retested. Assay recalibration may be
• Assay Diluent necessary. For troubleshooting information, refer to the ARCHITECT System
WARNING: Contains Polyethylene glycol octylphenyl Operations Manual, Section 10.
ether (Triton X-100) and Sodium Azide INSTRUMENT PROCEDURE
H319 Causes serious eye irritation. • Before performing the assay, the ARCHITECT HIV Ag/Ab Combo assay
EUH032 Contact with acids liberates very toxic gas. file must be installed on the ARCHITECT i System obtained from an
ARCHITECT i System Assay CD-ROM. For detailed information on assay
Prevention file installation and on viewing and editing assay parameters, refer to
P264 Wash hands thoroughly after handling. the ARCHITECT System Operations Manual, Section 2.
P280 Wear protective gloves / protective
• For information on printing assay parameters, refer to the ARCHITECT
clothing / eye protection.
System Operations Manual, Section 5.
Response • For a detailed description of system procedures, refer to the ARCHITECT
P305+P351 IF IN EYES: Rinse cautiously with water for System Operations Manual.
+P338 several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing. SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS
Verified Specimen Types
P337+P313 If eye irritation persists: Get medical
• Human serum (including serum collected in serum separator tubes)
advice / attention.
• Plasma collected in:
This material and its container must be disposed of in a
safe way. • potassium EDTA • sodium citrate
• sodium heparin • ACD, CPDA-I, CPD
• This product contains sodium azide. For a specific listing, refer to the
REAGENTS section. Contact with acids liberates very toxic gas. This • lithium heparin • potassium oxalate
material and its container must be disposed of in a safe way. • plasma separator tubes
• Safety Data Sheets are available at www.abbottdiagnostics.com or • The ARCHITECT i System does not provide the capability to verify
contact your local representative. specimen type. It is the responsibility of the operator to verify that
• For information on the safe disposal of sodium azide and a detailed the correct specimen types are used in the ARCHITECT HIV Ag/Ab
discussion of safety precautions during system operation, refer to the Combo assay.
ARCHITECT System Operations Manual, Section 8. • Performance has been established for the use of cadaveric blood
Handling Precautions specimens (specimens collected post-mortem, non-heart-beating), for
• Do not use reagent kits beyond the expiration date. details refer to section TESTING OF CADAVERIC BLOOD SPECIMENS.
• Do not pool reagents within a kit or between reagent kits. Specimen Conditions
• Prior to loading the ARCHITECT HIV Ag/Ab Combo Kit on the system • Do not use specimens with the following conditions:
for the first time, the microparticle bottle requires mixing to resuspend • heat-inactivated
microparticles that have settled during shipment. For microparticle • pooled
mixing instructions, refer to the PROCEDURE, Assay Procedure section • grossly hemolyzed (> 500 mg/dL)
of this package insert.
• obvious microbial contamination
• Septums MUST be used to prevent reagent evaporation and
contamination, and to ensure reagent integrity. Reliability of assay • body fluids other than human serum and plasma
results cannot be guaranteed if septums are not used according to • Ensure complete clot formation in serum specimens before
the instructions in this package insert. centrifugation. Some specimens, especially those from patients
• To avoid contamination, wear clean gloves when placing a septum receiving anticoagulant or thrombolytic therapy, may exhibit increased
on an uncapped reagent bottle. clotting time.
• Once a septum has been placed on an open reagent bottle, do • Specimens from heparinized patients may be partially coagulated and
not invert the bottle as this will result in reagent leakage and may contain fibrin. Draw the specimen prior to heparin therapy.
compromise assay results. • For accurate results, serum and plasma specimens should be free of
• Over time, residual liquids may dry on the septum surface. These are fibrin, red blood cells or other particulate matter.
typically dried salts, which have no effect on assay efficacy. • Use caution when handling patient specimens to prevent cross
• For a detailed discussion of handling precautions during system contamination. Use of disposable pipettes or pipette tips is
operation, refer to the ARCHITECT System Operations Manual, recommended.
Section 7. • For optimal results, inspect all specimens for bubbles. Remove bubbles
with an applicator stick prior to analysis. Use a new applicator stick
Storage Instructions for each specimen to prevent cross contamination.
• No qualitative performance differences were observed between
experimental controls and more than 20 nonreactive or more than
• The ARCHITECT HIV Ag/Ab Combo Reagent Kit must be 20 spiked reactive specimens tested with elevated levels of bilirubin
stored at 2-8°C and may be used immediately after removal from 2-8°C (20 mg/dL), triglycerides (3000 mg/dL), protein (4 - 12 g/dL), red blood
storage. The reagent kit must be stored in an upright position. cells (0.4% v/v), or hemoglobin (500 mg/dL).
• The ARCHITECT HIV Ag/Ab Combo Reagent Kit may be stored on board
the ARCHITECT i System for a maximum of 30 days. After 30 days, the
reagent kit must be discarded. For information on tracking onboard time,
refer to the ARCHITECT System Operations Manual, Section 5.

3
Preparation for Analysis • 4J27-03 ARCHITECT HIV Ag/Ab Combo Calibrator
• Specimens must be separated from clots or red blood cells using • 4J27- 12 ARCHITECT HIV Ag/Ab Combo Controls
centrifugation as recommended by the tube manufacturer. Gravity • ARCHITECT i
separation is not sufficient for specimen preparation. • ARCHITECT i
• To ensure consistency in results, specimens containing particulate • ARCHITECT i
matter or red blood cells, specimens that have been thawed, and
specimens that require retesting must be transferred to a centrifuge • ARCHITECT i
tube and centrifuged at ≥ 10,000 RCF (Relative Centrifugal Force) • ARCHITECT i
for 10 minutes prior to testing. • ARCHITECT i
• Mix thawed specimens by inverting 10 times. Visually inspect the • ARCHITECT i
specimens for the absence of stratification. If layering or stratification • Pipettes or pipette tips (optional) to deliver the volumes specified on
is observed repeat inversion cycles until specimens are visibly the Patient or Control order screen.
homogeneous. Centrifuge prior to testing. For information on materials required for maintenance procedures, refer to
• Centrifuged specimens with a lipid layer on the top must be transferred the ARCHITECT System Operations Manual, Section 9.
to a sample cup or secondary tube. Care must be taken to transfer
Assay Procedure
only the clarified specimen without the lipemic material.
• Before loading the ARCHITECT HIV Ag/Ab Combo Reagent Kit on the
Storage system for the first time, the microparticle bottle requires mixing to
• Serum or plasma specimens should be stored for no longer than 3 days resuspend microparticles that have settled during shipment:
at room temperature (15 to 30°C) or 14 days at 2 to 8°C following • Invert the microparticle bottle 30 times.
specimen collection. If a storage period greater than 3 days at room • Visually inspect the bottle to ensure microparticles are
temperature or 14 days at 2 to 8°C is anticipated, the specimens should resuspended. If microparticles remain adhered to the bottle,
be removed from the clot, red blood cells, or separator gel, and the continue inverting the bottle until the microparticles have been
serum or plasma should be stored frozen at - 20°C or colder. completely resuspended.
• No qualitative performance differences were observed between • If the microparticles do not resuspend, DO NOT USE.
experimental controls and 25 nonreactive or 25 spiked reactive
• Once the microparticles have been resuspended, remove and
specimens subjected to 6 freeze/thaw cycles; however, multiple
discard the cap. Wearing clean gloves, remove a septum from the
freeze/thaw cycles should be avoided.
bag. Carefully snap the septum onto the top of the bottle.
Shipping • Order calibration, if necessary.
• Before shipping specimens, it is recommended that specimens be • For information on ordering calibrations, refer to the ARCHITECT
removed from the clot, separator, or red blood cells. System Operations Manual, Section 6.
• When shipped, specimens must be packaged and labeled in • Order tests.
compliance with applicable state, federal, and international regulations
• For information on ordering patient specimens and controls and
covering the transport of clinical specimens and infectious substances.
general operating procedures, refer to the ARCHITECT System
Specimens may be shipped at 2-8°C (wet ice), or at -20°C or colder
Operations Manual, Section 5.
(dry ice). Do not exceed the 14-day storage time for specimens shipped
at 2-8°C (wet ice). • Load the ARCHITECT HIV Ag/Ab Combo Reagent Kit on the ARCHITECT
i System.
TESTING OF CADAVERIC BLOOD SPECIMENS • Verify that all necessary reagents are present. Ensure that septums
• Performance has been established for the use of cadaveric blood are present on all reagent bottles.
specimens (specimens collected post-mortem, non-heart-beating) • The minimum sample cup volume is calculated by the system and
that have been collected up to 17.5 hours after death. Performance is printed on the Orderlist report. No more than 10 replicates may
was established using 50 spiked and 50 non-spiked cadaveric blood be sampled from the same sample cup. To minimize the effects of
specimens70. evaporation, verify adequate sample cup volume is present prior to
• Testing of cadaveric blood specimens from patients with plasma dilution running the test.
due to transfusions of > 2000 mL of blood or colloids within 48 hours, • Priority: 150 µL for the first ARCHITECT HIV Ag/Ab Combo test
or > 2000 mL of crystalloids within 1 hour (or any combination thereof) plus 100 µL for each additional HIV Ag/Ab Combo test from the
prior to collection of the specimens have not been validated. same sample cup.
• Follow general standards and/or regulations for collection, storage • ≤ 3 hours on board: 150 µL for the first ARCHITECT HIV Ag/Ab
and handling. Combo test plus 100 µL for each additional ARCHITECT HIV Ag/Ab
• Follow the tube manufacturer’s processing instructions for serum Combo test from the same sample cup.
or plasma collection tubes. After initial centrifugation, transfer the • > 3 hours on board: additional sample volume is required. For
supernatant to a centrifuge tube and centrifuge at 10,000 RCF (Relative additional information on sample evaporation and volumes, refer
Centrifugal Force) for 10 minutes. If specimens are not processed to the ARCHITECT System Operations Manual, Section 5.
directly after initial centrifugation, it is recommended to remove the
• If using primary or aliquot tubes, use the sample gauge to ensure
supernatant from the clot, red blood cells or separator gel until further
sufficient sample volume is present.
processing.
• Prepare calibrator and controls.
• Cadaveric blood specimens can be stored for up to 14 days at 2-8°C
or up to 3 days at 15-30°C following collection. • ARCHITECT HIV Ag/Ab Combo Calibrator 1 and Controls should
be mixed by gentle inversion prior to use.
• No qualitative differences were observed for cadaveric blood specimens
(nonreactive or spiked reactive) when subjected to up to 3 freeze / thaw • To obtain the recommended volume requirements for the
cycles. However, multiple freeze/thaw cycles should be avoided. ARCHITECT HIV Ag/Ab Combo Calibrator 1 and Controls, hold the
bottles vertically and dispense 20 drops of calibrator or 10 drops
PROCEDURE of each control into each respective sample cup.
Materials Provided: • Load samples.
• 4J27 ARCHITECT HIV Ag/Ab Combo Reagent Kit • For information on loading samples, refer to the ARCHITECT
Materials Required but not Provided: System Operations Manual, Section 5.
• ARCHITECT i System • Press RUN.
• ARCHITECT HIV Ag/Ab Combo Assay file, may be obtained from: • For optimal performance, it is important to follow the routine
• ARCHITECT i System e-Assay CD-ROM found on maintenance procedures defined in the ARCHITECT System Operations
www.abbottdiagnostics.com Manual, Section 9.
• ARCHITECT i System Assay CD-ROM

4
Specimen Dilution Procedures • The Interpretation of Results for specimens with a final result of
Specimens cannot be diluted for the ARCHITECT HIV Ag/Ab Combo reactive by the ARCHITECT HIV Ag/Ab Combo assay and indeterminate
assay. by supplemental testing is unclear; further clarification may be obtained
by testing another specimen taken three to six weeks later.
Calibration
• ARCHITECT HIV Ag/Ab Combo and supplemental assay results should
• To perform an ARCHITECT HIV Ag/Ab Combo calibration, test
be interpreted in conjunction with the patient’s clinical presentation,
Calibrator 1 in replicates of three. Calibrator 1 should be priority loaded.
history, and other laboratory results.
A single sample of each ARCHITECT HIV Ag/Ab Combo Control must
be tested to evaluate the assay calibration. Ensure that assay control NOTE: For details on configuring the ARCHITECT i System to use grayzone
values are within the S/CO ranges specified in the control package interpretations, refer to the ARCHITECT System Operations Manual,
insert. Section 2.
• Once an ARCHITECT HIV Ag/Ab Combo calibration is accepted and Flags
stored, all subsequent samples may be tested without further calibration • Some results may contain information in the Flags field. For a
unless one or both of the following occur: description of the flags that may appear in this field, refer to the
• A reagent kit with a new lot number is used ARCHITECT System Operations Manual, Section 5.
• Controls are out of range LIMITATIONS OF THE PROCEDURE
• For detailed information on how to perform an assay calibration, refer • If the assay results are inconsistent with clinical evidence, additional
to the ARCHITECT System Operations Manual, Section 6. testing is suggested to confirm the result.
QUALITY CONTROL PROCEDURES • Specimens from patients who have received preparations of mouse
The recommended control requirement for the ARCHITECT HIV Ag/Ab monoclonal antibodies for diagnosis or therapy may contain human
Combo assay is that a single sample of each control be tested once every anti-mouse antibodies (HAMA). Such specimens may show either
24 hours each day of use. falsely elevated or depressed values when tested with assay
If the quality control procedures in your laboratory require more frequent kits that employ mouse monoclonal antibodies.71,72 ARCHITECT
use of controls to verify test results, follow your laboratory-specific HIV Ag/Ab Combo reagents contain a component that reduces the
procedures. effect of HAMA reactive specimens. Additional clinical or diagnostic
information may be required to determine patient status.
The ARCHITECT HIV Ag/Ab Combo Control values must be within the
acceptable ranges specified in the control package insert. If a control is • Heterophilic antibodies in human serum can react with reagent
out of its specified range, the associated test results are invalid and must immunoglobulins, interfering with in vitro immunoassays.73 Patients
be retested. Recalibration may be indicated. routinely exposed to animals or to animal serum products can be prone
to this interference and anomalous values may be observed. Additional
It is recommended that each laboratory establish a control range for information may be required for diagnosis.
the ARCHITECT HIV Ag/Ab Combo Positive Control 1 when a new lot of
ARCHITECT HIV Ag/Ab Combo reagents is used. SPECIFIC PERFORMANCE CHARACTERISTICS
Verification of Assay Claims Precision
For protocols to verify package insert claims, refer to the ARCHITECT The ARCHITECT HIV Ag/Ab Combo demonstrated an imprecision of ≤ 14%
System Operations Manual, Appendix B. The ARCHITECT HIV Ag/Ab Combo for samples that were three times the cutoff value in a study where three
assay belongs to method group 5. calibrator lots, three control lots, and a panel consisting of four reactive
samples were tested. The study was performed at four external sites
RESULTS (France, Italy, Switzerland, Germany) each using one instrument and one
The ARCHITECT i System calculates the cutoff (CO) using the mean internal site using two instruments. Panel members were tested in replicates
chemiluminescent signal (RLU) from three replicates of the Calibrator 1 of three across two reagent lots at the external site and across three reagent
and stores the result. lots at the internal site. Each combination of instruments, panel members,
Calculation and reagent lots was tested in four runs, with the exception of one reagent
lot at the internal site that was tested in six runs on one instrument. The
The ARCHITECT i System calculates for the ARCHITECT HIV Ag/Ab Combo
intra-run and inter-run standard deviation (SD) and percent coefficient of
assay a result based on the ratio of the sample RLU(s) to the cutoff RLU
variation (%CV) were analyzed with a variance components analysis 74
for each specimen and control.
using a mixed analysis of variance model.75 The data from the study are
• Cutoff (CO) = Calibrator 1 mean RLU Value x 0.40 summarized in Table 1.*
• S/CO = Sample RLU/Cutoff RLU
Table 1
• The cutoff RLU is stored for each reagent lot calibration.
ARCHITECT HIV Ag/Ab Combo Precision
Interpretation of Results Panel Intra-assay Inter-assaya
• Specimens with S/CO values < 1.00 are considered nonreactive Member (units) n Mean SD %CV SD %CV
(NR).
Calibrator 1 (RLUs) 432 5629 201.8 3.6 235.7 4.2
• Specimens with S/CO values ≥ 1.00 are considered reactive (R).
NCb (S/CO) 1224 0.09 0.019 20.23 0.022 24.11
NOTE: All specimens that are initially reactive must be centrifuged
and retested in duplicate. Refer to the SPECIMEN COLLECTION and PCc 1 (S/CO) 1224 3.96 0.155 3.91 0.155 3.91
PREPARATION FOR ANALYSIS section in this package insert. PCc 2 (S/CO) 1224 3.57 0.115 3.22 0.161 4.51
ARCHITECT HIV Ag/Ab Combo Results PCc 3 (S/CO) 1224 3.19 0.107 3.34 0.141 4.41
Initial PMd 1 (S/CO) 432 2.57 0.098 3.82 0.137 5.33
Results Retest Final PMd 2 (S/CO) 432 2.44 0.116 4.76 0.146 6.01
(S/CO) Results Result Interpretation PMd 3 (S/CO) 432 2.36 0.075 3.16 0.097 4.12
R Both tests NR HIV p24 Ag and/or HIV-1/HIV-2 Ab PMd 4 (S/CO) 432 1.44 0.054 3.78 0.054 3.78
are NR not detected a Inter-assay variability contains intra-assay variability.
R One or both R Presumptive evidence of b Negative Control
tests are HIV p24 Ag and/or HIV-1/HIV‑2 Ab;
c Positive Control
reactive perform a supplemental assay
d Panel Member
NR No retest NR HIV p24 Ag and/or HIV-1/HIV-2 Ab
required not detected. * Representative performance data are shown. Results obtained at
individual laboratories may vary.

5
Specificity Table 4
The ARCHITECT HIV Ag/Ab Combo assay demonstrated a specificity of ARCHITECT HIV Ag/Ab Combo Sensitivity
≥ 99.5% in a study where specimens from a blood donor population with Antibody Total Reactive Sensitivity
an assumed HIV infection prevalence of zero were tested. The testing
Type n n (%)
was performed at two external sites and one internal site on a total of
6365 serum and plasma specimens collected from four blood-donation Anti-HIV-1 520 520 100.0
centers. Data from this study are summarized in Table 2.* Anti-HIV-2 111 111 100.0
Table 2 Anti-HIV gOa 6 6 100.0
ARCHITECT HIV Ag/Ab Combo Specificity a An additional 29 diluted anti-HIV gO specimens were found to be reactive
of Blood Donor Specimens by the ARCHITECT HIV Ag/Ab Combo assay.
Specimen Initially Repeat Specificity Specificity * Representative performance data are shown. Results obtained at
Type n Reactive Reactive (%) 95% CIa individual laboratories may vary.
Plasma 2747 3 3 99.89 99.68 - 99.98 Sensitivity of the ARCHITECT HIV Ag/Ab Combo assay to detect p24
Serum 3618 6 4 99.89 99.72 - 99.97 antigen and anti-HIV-1 was evaluated by testing sequential specimens from
Total 6365 9 7 99.89 99.77 - 99.96 31 seroconversion panels. These panels are commercially available and
precharacterized for HIV antigen and antibodies. Table 5 shows data from
a Confidence Interval 5 seroconversion panel members.*
* Representative performance data are shown. Results obtained at Table 5
individual laboratories may vary. ARCHITECT HIV Ag/Ab Combo Seroconversion Sensitivity
Specimens from randomly selected hospitalized patients and specimens ARCHITECT
containing potentially interfering substances, which includes those from Days HIV Ag/Ab
individuals with medical conditions unrelated to HIV infection, were tested Since 1st Combo Western HIV Aga PCRa
at four different sites with the ARCHITECT HIV Ag/Ab Combo assay. Of Panel Bleed (S/CO) Blota (S/CO) Copies/mL
the 2870 hospitalized patient specimens (HP) and the 322 specimens
BBI 0 0.12 Negb 0.1 4,000
containing potentially interfering substances (IS), 29 HP and 12 IS
specimens were confirmed as having HIV infection by confirmation testing. PRB953 3 1.04 Neg 0.6 80,000
These specimens were excluded from the study. The data from the 7 11.71 Neg 8.8 700,000
remaining 2841 HP specimens and the 310 IS specimens are summarized 10 31.79 Neg 19.3 1,000,000
in Table 3.* BBI 0 0.17 INDc (f24d) 0.3 1,000
Table 3 PRB955 3 1.86 IND (f24) 1.8 70,000
ARCHITECT HIV Ag/Ab Combo Specificity of 7 17.48 IND (f24) 14.0 400,000
Hospitalized Patients and Interfering Substances 12 24.62 IND (f24) 22.4 > 800,000
Specimen Initial Repeat Specificity 14 34.17 IND (24) 21.3 700,000
n
Type Reactive Reactive (%)
BBI 0 1.09 Neg 2.3 80,000
HP 2841 11 11 99.61
PRB959 7 323.59 Neg > 40.5 > 500,000
ISa 310 1 1 99.68
9 192.13 Neg > 40.5 > 500,000
Total 3151 12 12 99.62
14 75.41 p24, gp160 14.4 > 500,000
a The IS specimens belonged to the following categories: Viral infection
19 66.38 p24, gp160 0.7 200,000
(HBV, HSV, CMV, Rubella, HAV, HCV, EBV, HTLV-I, HTLV-II); fungal/ 21 66.29 p24, gp160 0.7 200,000
yeast/protozoal/bacterial infection (C. albicans, T. pallidum, T. gondii,
26 68.46 p24, gp160 1.1 300,000
E. coli, C. trachomatis, N. gonorrhea); autoimmune (rheumatoid
factor [RF], antinuclear antibodies [ANA]), other conditions (pregnant BCP 0 0.10 p24 0.255 < 400
females all trimesters, multiparous females, elevated IgG, elevated IgM, 6247 2 0.09 p24 0.373 < 400
monoclonal gammopathy, flu vaccine recipients, HAMA, hemodialysis 7 0.09 p24 0.343 < 400
patients, hemophiliacs, multiple transfusion recipients). 9 0.09 p24 0.343 < 400
* Representative performance data are shown. Results obtained at 14 0.09 p24 0.294 < 400
individual laboratories may vary.
16 0.09 p24 0.275 < 400
One hundred specimens from patients at increased risk for HIV infection
were tested by ARCHITECT HIV Ag/Ab Combo. Of these 100 specimens, 21 1.11 p24 1.265 23,600
70 were repeat reactive by ARCHITECT HIV Ag/Ab Combo. Sixty-nine of 23 7.65 p24 8.598 124,000
these 70 repeat reactive specimens were positive by confirmation testing.* 28 155.50 p24 37.618 675,000
The specimens from patients at increased risk for HIV infection belonged 30 129.37 Neg 39.941 > 750,000
to the following categories: Intravenous drug users, homosexual males, and NABI 0 0.12 INDc (p24) 0.45 2,326
sexually transmitted diseases.
SV404 8 0.13 IND (p24) 0.48 2,672
* These are representative performance data. Results obtained at individual
laboratories may vary. 11 0.13 IND (p24) 0.56 3,079
15 0.23 IND (p24) 0.52 7,190
Sensitivity
18 1.33 IND (p24) 1.48 54,380
The ARCHITECT HIV Ag/Ab Combo assay demonstrated the sensitivity
values provided in Table 4.* These values were determined in a study 22 6.51 IND (p24) 4.84 279,800
where specimens from individuals clinically diagnosed with HIV infection a Data from the vendor.
and classified disease status were tested. b Neg = no band or bands being observed.
c IND = indeterminant
d f24 = faint p24 antigen band
* Representative performance data are shown. Results obtained at
individual laboratories may vary.

6
The ARCHITECT HIV Ag/Ab Combo assay has an analytical sensitivity of 19. Loussert-Ajaka I, Chaix M-L, Korber B, et al. Variability of human
< 50 pg/mL to HIV-1 p24 Ag. Antigen sensitivity was evaluated with the immunodeficiency virus type 1 group O strains isolated from
HIV Ag 2003 AFSSAPS panel across three lots of ARCHITECT HIV Ag/ Ab Cameroonian patients living in France. J Virology 1995;69:5640-9.
Combo reagents. The results demonstrated an average sensitivity to 20. Soriano V, Gutiérrez M, García-Lerma G et al. First case of HIV‑1 group
HIV‑1 p24 Ag of 18.06 pg/mL.* In addition, sensitivity was assessed using O infection in Spain. Vox Sang 1996;71:66.
the HIV-1 p24 Antigen, First International Reference Reagent, NIBSC 21. Rayfield MA, Sullivan P, Bondea CI, et al. HIV-1 group O virus identified
code: 90/636. The results demonstrated an average sensitivity of 0.87 IU/ml.* for the first time in the United States. Emerging Infectious Diseases
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MD) Clade Panel consisting of 32 members with the following subtypes 22. Sullivan PS, Do AN, Robbins K, et al. Surveillance for variant strains of
was tested: A, B, B/A/B, C, D, G, F, Group O, CRF02_AG, CRF01_AE. For HIV: subtype G and group O HIV-1. JAMA 1997;278:292.
all panel members, the ARCHITECT HIV Ag/Ab Combo antigen sensitivity
23. Peeters, M. Recombinant HIV sequences: their role in the global
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Compendium 2000. Los Alamos, NM: Los Alamos National Laboratory,
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24. Montavon C, Toure-Kane C, Liegeois F, et al. Most env and gag subtype
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