On Tuesday, the FDA approved the first ever over-the-counter, at-home test for HIV. The test will offer customers complete privacy and could be on shelves in the States as soon as October.

OraQuick, developed by OraSure Technologies relies on a self-administered mouth swab and can deliver results within 20 to 40 minutes. Similar to a home-pregnancy test, a positive result does not mean that a person is definitely infected but rather provides solid grounds for a test to be performed in the appropriate medical setting.

“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,” the FDA said in a statement.

Following clinical studies, it was found that the test has “expected performance of 92% for test sensitivity” indicating a positive result.

“This means that one false negative result would be expected out of every 12 test results in HIV-infected individuals,” the FDA said.

The ground-breaking test is expected to be available as soon as October and may be found in as many as 30 000 stores across the USA.  The FDA hope that’s the test, which detects both type 1 and 2 HIV antibodies, will help to identify much larger numbers of previously undiagnosed cases.

When it hits the shelves, it’s expected to sell for more than $17, the price paid for a similar product used in hospitals and by doctors.

[Source: NY Times, Sky News]