Rapid HIV tests come in several formats: agglutination, flow through cassette, solid phase, and Immunochromatographic strip (ICS) tests. The tests that are commercially available today cover the range of specimen choice: whole blood, plasma, serum, and, since March 2004, oral swabs. Regardless of format or specimen, rapid HIV tests screen for antibody to HIV, and not for virus or viral load. Positive results require confirmation via standard EIA methods and, if positive, a further definition of the specific viral strain is required.
The Bio-Rad Multispot HIV-1/HIV-2 Rapid Test was approved by the FDA for clinical use in November, 2004. A landmark product, it was the first rapid HIV test to offer both detection (screening) and differentiation of HIV-1 and HIV-2 antibodies. The Multispot HIV-1/HIV-2 Rapid Test can be used with fresh and frozen plasma and serum, and takes about 10 minutes to perform. Sensitivity characteristics versus the Western Blot are impressive 100% for both HIV-1 and HIV-2 antibodies. Bio-Rad also offers standard testing systems (Western Blot and microplate format EIA) for screening and confirmatory testing.
Another ground breaking product in this arena is the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, marketed by Abbott Laboratories, Abbott Park, Ill. The OraQuick line was first introduced in 2002, and was the first CLIA-waived, rapid, point-of-care test designed to detect antibodies to HIV-1 using finger stick whole blood or venipuncture whole blood specimens. The updated OraQuick ADVANCE Rapid HIV-1/2 Antibody Test FDA approved in October 2004, can detect both HIV-1 and HIV-2 antibodies using oral fluid, finger-stick or venipuncture whole blood or plasma specimens. The test requires no specialized laboratory instrumentation, is portable, and can be st