BC 256
Alere HIV Combo
Alere HIV Combo

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.

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Sku:000444

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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

  1. 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.
  2. Desiccant Package
  3. 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.
  4. Quick Reference Card
  5. Package Insert
  6. Subject Information Notices: 25 in the 25 Test Units kit, and 100 in the 100 Test Units kit.
  7. Customer Letter
  8. 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.
  9. Disposable Workstations: 25 in the 25 Test Units kit, and 100 in the 100 Test Units kit.

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