FDA approved point-of-care test, Alere Determine HIV-1/2 Ag/Ab Combo Rapid Test detects both HIV-1/2 antibodies and free HIV-1 p24 antigen on a single test strip.
CLIA-Waived for fingerstick whole blood.
Features for the Alere Determine HIV-1/2 Ag/Ab Combo Rapid Test
- Built-in quality controls to let you know the test is working.
- Test in three simple steps with clear results in just 20 minutes.
- Test using whole blood, serum or plasma samples.
- Proved 99.9% overall clinical sensitivity for all sample types.
- A 4th generation test, with the ability to detect HIV earlier than 2nd and 3rd generation antibody-only tests.
Availability for the Alere Determine HIV-1/2 Ag/Ab Combo Rapid Test
| Model No. | Packaging |
| 7D2648 | 25 Tests |
| 7D2649 | 100 Tests |
Specifications for the Alere Determine HIV-1/2 Ag/Ab Combo Rapid Test
| 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 HIV-1/2 antibodies |
| 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) |
COMPONENTS OF ALERE DETERMINE™ HIV-1/2 Ag/Ab COMBO
MATERIALS PROVIDED
- Aluminum ziplock pouch containing Alere Determine™ HIV-1/2 Ag/Ab Combo Cards. Each Card consists of 5 or 10 Test Units which can be separated from each other by tearing along the perforated lines. Each Test Unit has a cover that is to be removed for sample application and visualization of test results.
- Desiccant Package
- Chase Buffer: 1 in the 25 Test Units kit, 2 in the 100 Test Units kit. Containing sodium chloride, disodium hydrogen phosphate, and Nipasept as a preservative.
- Quick Reference Card
- Package Insert
- Subject Information Notices: 25 in the 25 Test Units kit, and 100 in the 100 Test Units kit.
- Customer Letter
- Disposable Capillary Tubes: For collection and transfer of fingerstick samples. 25 in the 25 Test Units kit, and 100 in the 100 Test Units kit.
- Disposable Workstations: 25 in the 25 Test Units kit, and 100 in the 100 Test Units kit.
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