FDA Approved HIV Tests

Antigen/Antibody Laboratory Tests
Test Name and Manufacturer Instrument platform(s) Indication Run time Target analyte Reports Ag and Ab separately Detects IgG and/or IgM Specimen types and volume for initial run Frequency of external controls Least complexb CLIA category FDA product inserts
HIV Ag/Ab Combo (CHIV) Assay
Siemens Medical Solutions
ADVIA Centaur Aid in the diagnosis of HIV-1 and HIV-2 infection in pediatric and adult populations, including pregnant women <1 hour Antibodies to HIV-1 & HIV-2 &
HIV-1 p24 antigen
NO IgG and IgM Plasma, serum: 100 µL 8 hours on system Moderate ADVIA Centaur HIV Ag/Ab
HIV Ag/Ab Combo Assay
Abbott Diagnostics
ARCHITECT system (Alinity I) Aid in the diagnosis of HIV-1 and HIV-2 infection, including acute infection in adult and pediatric populations and pregnant women <30 mins Antibodies to HIV-1 & HIV-2 &
HIV-1 p24 antigen
NO IgG and IgM Plasma, serum: 150 µL Once every 24 hours Moderate Abbott ARCHITECT HIV Ag/Ab Combo
HIV Ag-Ab
Bio-Rad Laboratories, Inc.
BioPlex 2200 Aid in the diagnosis of infection with HIV‑1 and/or HIV‑2, including acute or primary HIV‑1 infection; may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects as young as two years of age, and pregnant women 45 mins Antibodies to HIV-1 & HIV-2 & HIV-1 p24 antigen YES IgG and IgM Plasma, serum: 350 µL At least once every 24 hours, and after each calibration Moderate BioPlex 2200 HIV Ag-Ab Assay
Elecsys HIV combi PT
Roche Diagnostics
Cobas e602 Aid in the diagnosis of HIV‑1 and/or HIV‑2 infection, including acute or primary HIV‑1 infection; may also be used as an aid in the diagnosis of HIV‑1 and/or HIV‑2 infection in subjects greater than 2 years of age and in pregnant women <30 mins Antibodies to HIV-1 & HIV-2 & HIV-1 p24 antigen NO IgG and IgM Plasma, serum: 39 µL Once every 24 hours when the test is in use, once per reagent kit, and following each calibration. Moderate Elecsys HIV combi PT
GS HIV Combo Ag/Ab EIA
Bio-Rad Laboratories, Inc.
open Aid in the diagnosis of HIV-1 or HIV-2 infection, including acute or primary HIV-1 infection
Aid in the diagnosis of HIV-1 or HIV-2 infection in pediatric subjects as young as two years of age
>3 hours HIV-1 Ab & HIV-2 Ab & HIV-1 p24 Ag NO IgG and IgM Plasma, serum: 75 µL Run with each plate High GS HIV Combo Ag/Ab EIA
HIV Combo Test
Ortho Clinical Diagnostics
VITROS ECi/ECiQ, 3600, 5600, XT 7600 For the simultaneous qualitative detection of antibodies to HIV types 1, including group M and O, and/or 2 (anti-HIV-1 and anti-HIV-2) and HIV p24 antigen in human serum and plasma (heparin and EDTA) in adults, including pregnant women, adolescents, and children (as young as 2 years of age). As an aid in the diagnosis of infection with HIV-1 or HIV-2 48 mins Antibodies to HIV-1 & HIV-2 & HIV-1 p24 antigen NO IgG and IgM Plasma, serum: 80 µL After calibration and at least once every 24 hours Moderate VITROS Immunodiagnostic Products HIV Combo Reagent Pack
Elecsys HIV Duo
Roche Diagnostics
Cobas e801 Aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute and primary HIV-1 infection <30 mins HIV-1 Ab & HIV-2 Ab & HIV-1 p24 Ag YES IgG and IgM Plasma, serum: 60 µL After calibration and at least once every 24 hours Moderate Elecsys HIV Duo
Antibody Laboratory Tests
Test Name and Manufacturer Instrument platform(s) Indication Run time Target analyte Reports Ag and Ab separately Detects IgG and/or IgM Specimen types and volume for initial run Frequency of external controls Least complexb CLIA category FDA product inserts
HIV 1/O/2 Enhanced (EHIV) Assay
Siemens Medical Solutions USA, Inc.
ADVIA Centaur/Centaur XP Qualitative determination of antibodies to HIV type 1, including Group O, and/or type 2 <1 hour Antibodies to HIV-1 & HIV-2 NO IgG and IgM Plasma/serum: 50 µL Before and after a specimen or batch of specimens Moderate ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack
Avioq HIV-1 Microelisa System
Avioq, Inc.
open Aid in diagnosis of infection with HIV-1 >3 hours Antibodies to HIV-1 NO IgG and IgM Plasma, serum, oral fluid, dried blood spots: 15 μL; dried blood spot  ¼” punch Each run High Avioq HIV-1 Microelisa System
GS HIV-1/2 Plus O
BioRad Laboratories, Inc.
open Screening test for specimens from individual human donors
Aid in the diagnosis of infection with HIV-1 and/or HIV-2
>3 hours Antibodies to HIV-1 & HIV-2 NO IgG and IgM Plasma, serum and cadaveric serum: 75 µL Each plate High GS HIV-1/2 Plus O
Anti-HIV 1+2
Ortho Clinical Diagnostics
VITROS ECi/ECiQ, VITROS 3600, VITROS 5600, VITROS XT 7600 For the in vitro detection of antibodies to Human Immunodeficiency virus types HIV-1 and/or HIV-2 in human serum and plasma. As an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in persons with signs or symptoms of, or at risk for, HIV infection <1 hour Antibodies to HIV-1 & HIV-2 NO IgG and IgM Plasma, serum: 80 µL After calibration and at least once every 24 hours Moderate VITROS Immunodiagnostics Products Anti-HIV 1+2
Antigen/Antibody Rapid Tests
Test Name and Manufacturer Instrument platform(s) Indication Run time Target analyte Reports Ag and Ab separately Detects IgG and/or IgM Specimen types and volume for initial run Frequency of external controls Least complexb CLIA category FDA product inserts
DetermineHIV-1/2 Ag/Ab Combo
Abbott
N/A Point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2, including an acute HIV-1 infection, and may distinguish acute HIV-1 infection from established HIV-1 infection 20 mins Antibodies to HIV-1 & HIV-2 & HIV-1 p24 antigen YES IgG and IgM Whole blood, serum, plasma: 50 µL Prior to testing patient specimens when a new operator performs testing, a new test kit lot is to be used, a new shipment of test kits received Waived for fingerstick whole blood; moderate for venous whole blood, serum and plasma samples. Alere Determine HIV-1/2 Ag/Ab Combo
Antibody Rapid Tests
Test Name and Manufacturer Instrument platform(s) Indication Run time Target analyte Reports Ag and Ab separately Detects IgG and/or IgM Specimen types and volume for initial run Frequency of external controls Least complexb CLIA category FDA product inserts
OraQuick In-Home HIV Test
OraSure Technologies, Inc.
N/A Over the counter; in-vitro diagnostic home-use test 20 mins Antibodies to HIV-1 & HIV-2 NO IgG and IgM Oral fluid: oral swab No external controls N/A OraQuick In-Home HIV Test
Antibody Rapid Tests
Test Name and Manufacturer Instrument platform(s) Indication Run time Target analyte Reports Ag and Ab separately Detects IgG and/or IgM Specimen types and volume for initial run Frequency of external controls Least complexb CLIA category FDA product inserts
DPP HIV-1/2 Assay
Chembio Diagnostics Inc.
N/A Point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2 10 mins WB/25 mins OF Antibodies to HIV-1 & HIV-2 NO IgG and IgM Whole blood, oral fluid: 10 μL oral swab Each new operator; new test kit lot; new shipment of test kits received; if the temperature of the test storage area falls outside of 2 to 30°C (36 to 86°F); if the temperature of the testing area falls outside of 18 to 30°C (64 to 86°F; at periodic intervals as indicated by the user facility CLIA waived for fingerstick whole blood CLIA moderate complexity for venous whole blood and plasma Chembio DPP HIV 1/2 Assay
HIV 1/2 STAT-PAK Assay
Chembio Diagnostics Inc.
N/A Point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms 15 mins Antibodies to HIV-1 & HIV-2 NO IgG and IgM Whole blood: 5 µL Each new operator; new test kit lot;  new shipment of test kits received; if the temperature of the test storage area falls outside of 8 to 30°C (46 to 86°F); if the temperature of the testing area falls outside of 18 to 30°C (64 to 86°F) CLIA waived for fingerstick whole blood CLIA moderate complexity for venous whole blood and plasma Chembio HIV 1/2 STAT-PAK Assay
INSTI HIV-1/HIV-2 Antibody Test
bioLytical
N/A Aid in the diagnosis of HIV-1 and/or HIV-2 infection in point-of-care settings <2 mins Antibodies to HIV-1 & HIV-2 NO IgG and IgM Fingerstick whole blood, venous whole blood and plasma: 50 µL For new INSTI operator verification prior to performing testing on patient specimens; when switching to a new lot number of INSTI test kits; whenever a new shipment of kits is received; when temperature during storage of the kit falls outside of 15° to 30°C (59° to 86°F); when the temperature of the test area falls outside of 15° to 30°C (59° to 86°F); at regular intervals as determined by the user facility CLIA waived for fingerstick whole blood
CLIA moderate complexity for venous whole blood and plasma
INSTI HIV-1/HIV-2 Antibody Test
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
OraSure Technologies
N/A Point-of-care test to aid in the diagnosis of infection with HIV-1 or HIV-2 20 mins Antibodies to HIV-1 & HIV-2 NO IgG and IgM 5 µL of whole blood,  plasma, or oral fluid  swab Each new operator prior to performing testing on patient specimens,
when opening a new test kit lot, whenever a new shipment of test kits is received, if the temperature of the test kit storage area falls outside of 2C to 27C (35 to 80°F), if the temperature of the testing area falls outside of 15C to 37C (59 to 99°F), and at periodic intervals as dictated by the user facility
CLIA waived for fingerstick whole blood CLIA moderate complexity for venous whole blood and plasma OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
Reveal G4 Rapid HIV-1 Antibody Test
MedMira Laboratories, Inc.
N/A Point-of-care test to aid in the diagnosis of infection with HIV -1 <2 mins Antibodies to HIV-1 NO IgG 1 drop whole blood, serum, plasma Each run Moderate Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4)
SURE CHECK HIV 1/2 Assay
Chembio Diagnostics Inc.
N/A As a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. 15 mins Antibodies to HIV-1 & HIV-2 NO IgG and IgM Whole blood: 2.5 μL Each new operator; new test kit lot; new shipment of test kits received; if the temperature of the test storage area falls outside of 2 to 30°C (36 to 86°F); if the temperature of the testing area falls outside of 18 to 30°C (64 to 86°F; at periodic intervals as indicated by the user facility Waived Chembio SURE CHECK HIV 1/2 Assay
Uni-Gold Recombigen HIV-1/2
Trinity Biotech
N/A For use in point of care settings as an aid in diagnosis of infection with HIV-1 or HIV-2 10 mins Antibodies to HIV-1 & HIV-2 NO IgG and IgM Plasma, serum, whole blood: premeasured pipette All new operators; each new kit lot; new shipment of test kits; if the temperature of the test kit storage area falls outside of 2 to 27°C (35.6   to 80.6°F); if the temperature of the testing area falls outside of 15 to 27°C (59.0 to  80.6°F) Waived Uni-Gold Recombigen HIV-1/2 | FDA
DPP HIV-Syphilis System
Chembio Diagnostics Inc.
N/A Aid in the diagnosis of HIV and syphilis infection 10 mins

Antibodies to HIV-1 & HIV-2 or Treponema pallidum

NO IgG and IgM Fingerstick whole, venous blood or plasma: 10 µL Each new operator prior to performing tests on patient samples; when opening a new test kit lot; whenever a new shipment of test kits is received; if the temperature of the test storage area falls outside of 2 to 30°C (36 to 86°F); if the temperature of the testing area falls outside of 18 to 30°C (64 to 86°F); at periodic intervals as indicated by the user facility Waived  CLIA – Clinical Laboratory Improvement Amendments (fda.gov) enter CW210001 into ‘Document Number’
Diagnostics Nucleic Acid Laboratory Tests
Test Name and Manufacturer Instrument platform(s) Indication Run time Target analyte Detects antibody/antigen Specimen types and volume for initial run Frequency of external controls Least complexb CLIA category FDA product inserts
HIV-1/HIV-2 Qualitative, MPX
Roche Molecular Systems, Inc.
cobas 6800, 8800 Aid in diagnosis of HIV-1/HIV-2 infection. Detection of HIV-1 or HIV-2 nucleic acid is indicative of HIV-1 or HIV-2 infection, respectively LTR/gag (HIV-1)
LTR (HIV-2)
N/A EDTA Plasma Serum: 0.65 mL On-board max 8 hours for HIV-1/HIV-2 Qualitative control kit Moderate cobas HIV-1/HIV-2 Qualitative
Aptima HIV-1 Quant Dx Assay
Aptima® HIV-1 Quant Dx Assay | Hologic
Hologic Panther

Aid in diagnosis for HIV-1
infection using appropriate HIV testing algorithms. The presence of HIV-1 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 is indicative of acute or primary Infection.
As a supplemental test to confirm HIV-1 infections when reactive screening assays.

Aid in monitoring the effects of antiretroviral therapy

 Approximately 3 hours (including reagent preparation time and quality control processing time) LTR/pol N/A EDTA/ACD Plasma Serum: 0.7 mL On-board max 24 hours for Controls and Calibrators High Aptima HIV-1 Quant Dx Assay
Alinity m HIV-1
Alinity m HIV 1Assay
Alinity m

Aid in the clinical management of HIV-1 infected individuals in conjunctions with clinical presentation and other laboratory markers. It is not intended for use in screening blood, blood products, tissue, or organ donors for HIV.

< 2 hours to
first result
LTR/pol N/A Serum or Plasma
(ACD, K2
EDTA, K3
EDTA,
and PPT):
0.75-1.4mL
Serum for diagnosis; viral load requires plasma
On-board Three level controls at least once every 24 hours Moderate Alinity m HIV-1
Supplemental Antibody Laboratory Tests
Test Name and Manufacturer Instrument platform(s) Indication Run time Target analyte Reports Ag and Ab separately Detects IgG and/or IgM Specimen types and volume for initial run External quality control required Least complexb CLIA category FDA product inserts
Geenius HIV 1/2 Supplemental System
Bio-Rad Laboratories, Inc.
Geenius Reader As an aid in the diagnosis of infection with HIV-1 and/or HIV-2; test to confirm the presence of antibodies to HIV-1 and HIV-2 for specimens found to be repeatedly reactive by diagnostic screening procedures; adults 20 mins

Differentiates HIV-1 and HIV-2 antibodies

NO IgG Whole blood, serum /plasma: 5 uL serum or plasma, 15 uL whole blood When opening a new test kit lot and when a new shipment of test kits is received; If the temperature of the test storage area falls outside of 2 to 30°C (36 to 86°F); If the temperature of the testing area falls outside of 18 to 30°C (64 to 86°F)At Moderate Geenius HIV 1/2 Supplemental Assay
Genetic Systems HIV-1 Western Blot
Bio-Rad Laboratories, Inc.
open Supplemental assay for the detection and identification of antibodies to HIV-1 3 hrs Antibodies to HIV-1 NO IgG and IgM Plasma, serum, dried blood spots: 10 µL or ¼” punch Each run High
VioOne HIV Profile Supplemental Assay
Avioq, Inc
open Confirmation and differentiation of individual antibodies to HIV-1 and Type 2 >2 hours Antibodies to HIV-1 and HIV-2 NO IgG Plasma, serum: 20 µL Each strip High VioOne HIV Profile Supplemental Assay
Cambridge Biotech HIV-1 Western Blot Urine Kit
Maxim Biomedical, Inc.
open Supplemental test; as an aid in clinical diagnosis of HIV infection ~24 hrs Antibodies to HIV-1 NO IgG Urine: 1ml Each run High Cambridge Biotech HIV-1 Western Blot Kit

Footnote: Discontinued tests: OraSure HIV-1 Western Blot; Murex HIV Ab/Ag HT Assay; Cambridge Biotech HIV-1 Serum Western Blot; Aptima HIV-1 RNA Qualitative Assay (last reagents available Sept 2021); Multispot HIV 1/HIV 2 Rapid Test, LIAISON XL Murex HIV Ab/Ag HT; Cambridge Biotech HIV 1 Serum; Fluorognost HIV 1 IFA.

Nucleic Acid Monitoring Tests – Not for Diagnosis
Test Name
and
Manufacturer
Instrument
platform(s)
Indication Run
time
Target analyte Detects antigen/
antibody
Specimen types and volume for initial run Frequency of external controls Least
complexb
CLIA
category
FDA product
inserts
Cobas HIV-1
cobas® HIV-1 Test (roche.com)
cobas 6800,
8800
As a supplemental test, when reactive, to confirm HIV-1 infection in individuals whose plasma or serum was also reactive an approved screening assays. Is not intended as aid in diagnosis or to confirm HIV-1 infection. Approximately 3 hours for first result (including reagent preparation
time and quality control processing time)
LTR/gag N/A EDTA Plasma:0.65 mL Three level controls on each plate Moderate cobas HIV-1
AmpliPrep/COBAS
TaqMan HIV-1
Test, version 2.0
COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (roche.com)
COBAS TaqMan/COBAS TaqMan 48 Analyzer Aid in the clinical management of HIV-1 infected individuals in conjunctions with clinical presentation and other laboratory markers.
It is not intended as aid in diagnosis or to confirm HIV-1 infection.
>3 hours (including reagent preparation time and quality control processing time)

LTR/gag

N/A EDTA Plasma: 1.0 mL Three level controls in ever run Moderate MS – COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 IVD, Lot J04272 (08/23), #05212308190 (roche.com)

COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L | FDA

Aptima HIV-1 Quant Dx Assay
Aptima® HIV-1 Quant Dx Assay | Hologic
Hologic Panther Aid in diagnosis for HIV-1
infection using appropriate HIV testing algorithms. The presence of HIV-1 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 is indicative of acute or primary Infection. As a supplemental test to confirm HIV-1 infections when reactive screening assays. Aid in monitoring the effects of antiretroviral therapy.
>3 hours (including reagent preparation time and quality control processing time) LTR/pol N/A EDTA Plasma: 0.7 mL On-board max 24 hours for Controls and Calibrators High Aptima HIV-1 Quant Dx Assay
RealTime HIV-1
RealTime HIV-1 Viral Load Assay | Abbott Molecular
m2000 Aid in the clinical management of HIV-1 infected individuals in response to antiretroviral therapy in conjunctions with clinical presentation and other laboratory markers. It is not intended as aid in diagnosis or to confirm HIV-1 infection. >3 hours (including reagent preparation time and quality control processing time) pol (integrase N/A Plasma (ACD-A and EDTA): 0.2- 1.0 mL Three level controls in each run High Abbott RealTime HIV-1 Amplification