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FDA approves “instant” HIV home test

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e4636 (Published 05 July 2012) Cite this as: BMJ 2012;345:e4636
  1. Bob Roehr
  1. 1Washington, DC

The US Food and Drug Administration has approved the first true over the counter self administered test for HIV. The OraQuick In-Home HIV Test is manufactured by OraSure Technologies.

The test consists of a swab to collect an oral fluid sample from the gums of the mouth, which is then placed in a developer vial to measure antibodies to the virus. The test produces results in 20 to 40 minutes in much the same way as a home pregnancy test.

It has a specificity of 99.98%, resulting in one false positive result in every 5000 tests …

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