FDA Approved HIV 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 |
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 |
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 |
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 |
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’ |
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 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 |
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.
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) |
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 |
This section focuses on FDA-approved diagnostic HIV tests for use in moderate and high complexity laboratories.
Laboratory Testing Guidance
- 2018 Quick Reference Guide: Recommended laboratory HIV testing algorithm for serum or plasma specimens
- Updated January 2019 APHL Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm
- Full Version of the Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations
- Technical Update on HIV-1/2 Differentiation Assays, August 2016
- Technical Update: Use of the Determine HIV 1/2 Ag/Ab Combo Test with Serum or Plasma in the Laboratory Algorithm for HIV Diagnosis
Resources
- Fact Sheet: False Positive HIV Test Results [PDF – 130 KB]
- Selecting an HIV Test: A Narrative Review for Clinicians and Researchers
- The Evolution of HIV Testing Continues
- Highlights from the 2016 HIV diagnostics conference: The new landscape of HIV testing in laboratories, public health programs and clinical practice
- New HIV Testing Technologies: Implications for your Laboratory
- Association of Public Health Laboratories (APHL) HIV Testing Resources (includes recent manufacturer news)
- Detection of Acute HIV Infection in Two Evaluations of a New HIV Diagnostic Testing Algorithm — United States, 2011–2013
- 2013 Journal of Clinical Virology Supplement: HIV Laboratory Diagnosis: New Tests and a New Algorithm.
(Select year 2013 then Vol. 58 December, 2013 p.e1-e134-Supplement 1) - HIV Diagnostics Conference