Introducing the first FDA approved rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen. This 4th generation test has the ability to identify HIV earlier than 2nd and 3rd generation antibody-only tests.1 It enables health care providers to diagnose HIV infection earlier allowing individuals to seek medical care sooner.
Now CLIA-Waived for fingerstick whole blood!
Only available in the US.
CLIA-waived for fingerstick whole blood
It’s the first 4th generation 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.
A 4th generation test, with the ability to detect HIV earlier than 2nd and 3rd generation antibody-only tests. 1
Test using whole blood, serum or plasma samples.
Proved 99.9% overall clinical sensitivity for all sample types.
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 |
12 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 |
Determine™ HIV-1/2Ag/Ab Combo (100 Tests) |
7D2649 |
External Controls |
7D2628 |
Fingerstick Sample Collection Kit (100 Sterile Safety Lancets, 100 Adhesive Bandages, 100 Ethanol Swabs, 100 Gauze Pads) |
2604US199 |
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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