Product Description
The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test is a single-use, point-of-care test designed to qualitatively detect antibodies to HIV-1 and HIV-2 in oral fluid, fingerstick whole blood, venipuncture whole blood, and plasma specimens. With visually read results available in as little as 20 minutes, it helps healthcare professionals provide timely HIV screening and support prompt linkage to appropriate follow-up care.
Its flexible specimen options—including a non-invasive oral fluid collection method—make it well suited for clinical laboratories, physician offices, community testing programs, mobile clinics, and other outreach settings. The test is CLIA-waived for oral fluid, fingerstick whole blood, and venipuncture whole blood specimens; plasma testing is moderately complex.
Proven Performance
OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test delivers strong performance across approved specimen types, with reported sensitivity of 99.3% for oral fluid and 99.6% for fingerstick whole blood and plasma. Specificity is reported at 99.8% for oral fluid, 100.0% for fingerstick whole blood, and 99.9% for plasma. Reactive results are preliminary and should be followed by confirmatory testing according to applicable testing algorithms.
Features & Benefits
- Rapid Results: Provides results in 20 minutes, enabling patients to learn their status in a single visit and allows HIV positive patients to be connected to care immediately.
- Accurate – Delivers greater than 99% sensitivity and specificity across approved specimen types, with oral fluid sensitivity of 99.3%, fingerstick whole blood sensitivity of 99.6%, and plasma sensitivity of 99.6%.
- Flexible: Approved for oral fluid, plasma, fingerstick or venipuncture whole blood specimens. Ideal for both clinical and non-clinical settings.
- Simple: CLIA-waived for oral fluid, fingerstick and venipuncture whole blood and offers the ability to test in non-traditional testing environments, such as outreach programs and mobile testing clinics.
