FDA Approves Rapid HIV Home Test

Posted on 13 July 2012

FDA Approves Rapid HIV Home Test


WASHINGTON, D.C. – Last week, the Food and Drug Administration (FDA) approved a new home test that will, for the first time, make it possible for Americans to learn their HIV status. OraQuick, the test developed by OraSure Technologies, utilizes a mouth swab, providing results within approximately 20 to 40 minutes. A previous test that was sold over the counter provided lab test results that were determined by the user pricking his finger.

Approximately 50,000 people contract HIV each year. According to the Centers for Disease Control and Prevention (CDC), testing and treatment are crucial elements to HIV/AIDS prevention, since an infected person who uses antiretroviral drugs is as much as 96 percent less likely to transmit the virus to someone else. Officials estimate that of the 1.2 million Americans living with HIV/AIDS, 20 percent are unaware they have it.

The concept of HIV home tests has long been surrounded by controversy. Although the first application for a home test was made in 1987, some advocates expressed alarm over privacy concerns, and the potential for public exposition of one’s HIV status. In addition, some concerned activists predicted that home tests might precipitate suicides, and referenced the death of a San Francisco man who jumped off the Golden Gate Bridge after learning he was HIV-positive.

Dr. Robert Gallo, a senior National Institutes of Health (NIH) researcher who supervised the lab that developed the first U.S. HIV blood test in 1984, called the FDA approval “wonderful, because it will get more people into care.”

Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases (NIAID), said the new test is a “positive step forward,” which could finally bring under control the 30-yearold epidemic. Because the home test was approved for people aged 17 years and older, stores may ask for customers’ ID at the time of purchase.

 

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