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First OTC test for HIV available in the US

OraQuick In-Home HIV Test could “break down barriers” for people unaware they have HIV

The US Food and Drug Administration (FDA) has given its approval to what will be the first HIV test available for home use in the country.

The OraQuick In-Home HIV Test will be available over-the-counter (OTC) and gives users their results some 20-40 minutes after they their own saliva sample and place into a developer vial that can detect HIV antibodies.

According to HIV and AIDS charity, Avert, it is expected that once the kit becomes available in stores, it will greatly improve access to testing in the US, where currently one in five of the 1.2m people living with HIV are unaware of their status.

“The US has the largest number of people living with HIV in the industrialised world, with tens of thousands of people newly infected every year ... many of these new infections are transmitted by those unaware of their status,” the charity said in a statement.

“It is hoped that the OraQuick test will help break down barriers that stand in the way of people coming forward for testing.”

Despite these expectations, the FDA pointed out results were not definitive, and anybody who receives a positive test should seek additional testing in a medical setting, with one false negative result  expected out of every 12 test results in HIV-infected individuals.

Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months, with one false positive expected out of every 5,000 test results in people without HIV.

It is estimated by the US Centers for Disease Control and Prevention that 1.2m people in the United States are living with HIV infection.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Dr Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. “The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.”

The test's manufacturer, OraSure Technologies, has set up a consumer support system for users that will provide a 24-hour telephone advice line to offer users information about HIV/AIDS, the proper method for administering the test and guidance on what to do when they get their results.

5th July 2012

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