US FDA approves at-home HIV test

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The US Food and Drug Administration has approved a rapid, at-home HIV test for the first time.

OraQuick, which will sold over-the-counter, is an oral swab test which gives a result in 20-40 minutes.

The FDA said in a statement: “The test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods.”

Dr Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, added: “Knowing your status is an important factor in the effort to prevent the spread of HIV.

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 FDA said that while a positive result is not a definite diagnosis of HIV infection, it means individuals should seek further testing.

Similarly, it added: “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.”

It is estimated that 1.2 million Americans are HIV-positive, with a fifth of these unaware of their HIV status.

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