Global Point of Care
The first FDA approved rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen. This antigen/antibody test (4th generation) has the ability to identify HIV earlier than antibody-only tests (2nd and 3rd generation).1 It enables health care providers to diagnose HIV infection earlier allowing individuals to seek medical care sooner.
Only available in the US.
CLIA-waived for fingerstick whole blood
It’s the first antigen/antibody rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen on a single test strip.
Built-in quality controls to let you know the test is working.
Test in three simple steps with clear results in just 20 minutes.
The first antigen/antibody test, with the ability to detect HIV earlier than antibody-only tests.1
Test using whole blood, serum or plasma samples.
Proved 99.9% overall clinical sensitivity for all sample types.
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By detecting HIV earlier, you are helping to prevent further transmission during this extremely infectious early stage.
Information Type | Product Detail |
Method | Lateral Flow |
Time to results | 20 minutes |
Results window | 20-30 minutes after starting test |
Test lines | HIV-1 p24 antigen |
Storage conditions | 2-30°C (36-86°F) |
Test shelf life | 24 months* |
External controls shelf life | 24 months** |
Sample type | Wholeblood/serum/plasma |
Operating temperature | 15-30°C (59 to 86°F) |
Sample Type | Overall Clinical | Overall Clinical |
Fingerstick Whole Blood | 99.9% | 99.8% |
Venous Whole Blood | 99.9% | 99.7% |
Serum | 99.9% | 99.6% |
Plasma | 99.9% | 99.7% |
Determine™ HIV-1/2 Ag/Ab | Code |
Determine™ HIV-1/2Ag/Ab Combo (25 Tests) | 7D2648 |
External Controls | 7D2628 |
Verification Panel | KZMC030 |
1. Masciotra, S, et al. Performance of the Alere Determine™ HIV-1/2 Ag/Ab Combo Rapid Test with specimens from HIV-1 seroconverters from the US and HIV-2 infected individuals from Ivory Coast. J Clin Virol 2013: Published online 05 August 2013. DOI: 10.1016/j.jcv.2013.07.002 http://www.journalofclinicalvirology.com/article/S1386-6532(13)00277-1/abstract
2. Fiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibodyseroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS. 2003;17(13):1871-1879.
*Average shelf life received by customer (product has a 15 month shelf life from date of manufacture)
**From date of manufacture
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