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.

0 shares

Related Stories

FDA reviews first rapid, take-home test for HIV

date 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

date 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

date 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

date 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

HIV prevention and risk behaviors follow weekly patterns

date 40 minutes ago

The peak time for seeking information on topics related to HIV, such as prevention and testing, is at the beginning of the week, while risky sexual behaviors tend to increase on the weekends, according to a new analysis by ...

Mathematical model seeks functional cure for HIV

date 2 hours ago

(Medical Xpress)—Individuals with the natural ability to control HIV infection in the absence of treatment are referred to as elite controllers (ECs). Such individuals maintain undetectable viral loads ...

Indiana HIV outbreak, hepatitis C epidemic sparks US alert

date Apr 24, 2015

Federal health officials helping to contain an HIV outbreak in Indiana state issued an alert to health departments across the U.S. on Friday, urging them to take steps to identify and track HIV and hepatitis C cases in an ...

Why are HIV survival rates lower in the Deep South than the rest of the US?

date Apr 22, 2015

The Deep South region has become the epicenter of the US HIV epidemic. Despite having only 28% of the total US population, nine states in the Deep South account for nearly 40% of national HIV diagnoses. This region has the highest HIV diagnosis rates and the highest number of people living with HIV of any ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.