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FDA Approves New 60 Second HIV Antibody Test

The U.S. Food and Drug Administration (FDA) last week approved a new instant HIV antibody test that produces results in just 1 minute, compared to 10 to 20 minutes using previous rapid antibody assays. Shortening the wait for results could be particularly useful for tests done outside medical facilities, for example by outreach workers. The new test requires a blood draw or finger-stick, however, unlike some of the slower tests that use oral fluid. As with previous antibody assays, a positive result on the new INSTI test must be confirmed by a second, different test. 

Below is the edited text of an FDA announcement describing the new test.

December 2, 2010 -- On November 29, 2010, the Food and Drug Administration (FDA) announced the approval of the INSTI HIV-1 Antibody Test, a new, single use rapid test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human venipuncture whole blood, fingerstick blood, or plasma specimens. The newly approved test provides results in as little as 60 seconds, in contrast to the six previously approved rapid HIV tests, which typically deliver results in about 10-20 minutes.

Rapid HIV tests allow people to learn their HIV status in a single visit to a testing site, instead of returning days later for results, dramatically increasing the number of people who ultimately learn their serostatus after taking an HIV test.

Rapid testing also helps increase access to HIV testing because testing can be performed outside of the traditional laboratory setting. Individuals who undergo testing can be counseled immediately concerning their HIV status and, if they are positive, given the opportunity to enter medical care.

The INSTI HIV-1 Antibody Test can be used in clinical laboratories, in public health laboratories and in point-of-care settings. The test is classified as Moderate Complexity under CLIA (Clinical Laboratory Improvements Amendments).

It is highly sensitive [The overall sensitivity for the different sample types: 99.8% (95% CI = 99.3% - 99.9%) in fingerstick whole blood, 99.9% (95% CI = 99.5% - 100%) in venipuncture whole blood, 99.9% (95% CI = 99.5% - 100%) in plasma] and specific [The overall specificity for the different samples types: 99.5% (95% CI = 99.0% - 99.8) in fingerstick whole blood, 100% (95% CI = 99.7% - 100%) in venipuncture whole blood, 100% (95% CI = 99.7% - 100%) in plasma] for the detection of antibodies to HIV-1.

The assay is not intended to be used for screening of blood donors.

The INSTI HIV-1 Antibody Test is manufactured by bioLytical Laboratories Inc., Richmond, BC, Canada.



R Klein. FDA Approves New Rapid HIV Test Delivering Results in 60 Seconds. blog. December 3, 2010.

R Klein and K Struble (U.S. Food and Drug Administration). Approval of rapid INSTI HIV-1 Antibody Test. FDA Consumer Information. December 2, 2010.

bioLytical Laboratories. FDA Approves bioLytical Laboratories' INSTI Rapid HIV Test Innovative screening assay detects antibodies to HIV in as little as 60 Seconds. Press release. December 1, 2010.