FDA panel backs first rapid, take home HIV test

(AP) -- A panel of HIV specialists is recommending that U.S. regulators approve the first over-the-counter HIV test designed to quickly return a result in the privacy of a person's own home, a new option which could expand testing for the virus that causes AIDS.

The 17 members of the advisory panel voted unanimously that the benefits of OraQuick outweigh its potential risks for consumers. The test kit uses a mouth swab sample to detect the presence of HIV within 20 minutes.

The manufacturer OraSure already sells a version of the test to doctors and other health professionals. Studies showed the test was less accurate when used by consumers, but panelists said that the benefits of expanding HIV testing outweigh a small decrease in test accuracy.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA reviews first rapid, take-home test for HIV

May 11, 2012

The Food and Drug Administration is considering approval of the first over-the-counter HIV test that would allow consumers to quickly test themselves for the virus at home, without medical supervision.

Rapid oral HIV test shows great promise

Apr 11, 2007

A convenient, easy to use, and rapid alternative to blood-based HIV testing may become the new standard for field testing according to a new MUHC study. The study shows that the oral fluid-based OraQuick HIV1/2 test is 100 ...

FDA ignores critical information on home HIV tests

May 29, 2009

Los Angeles, London, New Delhi, Singapore and Washington DC (May 29, 2009) The FDA is ignoring critical information in deciding whether to approve an over-the-counter, rapid HIV test for home use, according to a recent article ...

Saliva HIV test passes the grade

Jan 24, 2012

A saliva test used to diagnose the human immunodeficiency virus (HIV), is comparable in accuracy to the traditional blood test, according to a new study led by the Research Institute of the McGill University Health Centre ...

Recommended for you

Intimacy a strong motivator for PrEP HIV prevention

Aug 19, 2014

Men in steady same-sex relationships where both partners are HIV negative will often forgo condoms out of a desire to preserve intimacy, even if they also have sex outside the relationship. But the risk of ...

UNL sociologist studies HIV spread in rural Puerto Rico

Aug 14, 2014

Puerto Rico has one of the highest HIV rates in the United States, primarily from drug users sharing needles. To help prevent HIV infections, a University of Nebraska-Lincoln sociologist is using his expertise ...

User comments