Regulatory Focus™ > News Articles > US Regulators Approve First Over-the-counter HIV Test Kit

US Regulators Approve First Over-the-counter HIV Test Kit

Posted 03 July 2012 | By Alexander Gaffney, RAC 

Regulators at the US Food and Drug Administration (FDA) announced Tuesday, 3 July the approval of an over-the-counter (OTC) home testing kit for the detection of the Human Immunodeficiency Virus (HIV)-the first of its kind to be approved.

The test, called the OraQuick In-Home HIV Test, is manufactured by Pennsylvania-based OraSure Technologies, Inc.

OraQuick received overwhelming approval from FDA's Blood product Advisory Committee in May 2012, voting 17-0 to recommend the test despite some early concerns regarding the test's accuracy or the possibility of false positives or false negatives.

FDA noted in its approval statement that OraQuick has a false negative rate of one out of every 12 (8.3%) tests, and a false positive rate of one out of every 5,000 (0.02%) tests.

As Regulatory Focusreported at the time, the committee's concerns were either assuaged or outweighed by the product's purported ability to help people determine their HIV status and prevent its spread to others. The test could prevent as many as 4,000 cases of HIV each year, reported Med Page Today-a reduction of approximately 8% of all new cases each year.

In a statement explaining the agency's approval of the device, FDA said the company has pledged to staff a consumer support center available 24 hours a day, seven days a week to educate consumers regarding the proper use of the product. "The center will be operational and available to educate users with information about HIV/AIDS, the proper method for administering the test and guidance on what to do once results have been obtained once the manufacturer makes the product available for sale to the public," FDA explained.

The test takes between 20 and 40 minutes to complete and is effective as early as three months after possible exposure to the virus.

Read more:

FDA - FDA approves first over-the-counter home use HIV test kit

Regulatory Focus - OTC Test for HIV Approved by FDA Advisory Panel

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