The FDA has approved a rapid at home HIV test.

OraSure Technologies Inc. of Bethlehem PA. has produced OraQuick for over-the-counter sales.

The hope is that the at-home test will reach the 20 percent of HIV infected people who do not know that they are infected.

Taking the test will not eliminate the need to follow up with further testing.

The test has the potential to identify large numbers of previously undiagnosed HIV infections. An estimated 1.2 million people in the U.S. are living with HIV infection. About one of every five don’t know they’re infected. About 50,000 new HIV infections are diagnosed every year.
percent accurate in correctly identifying positive results, a measure known as sensitivity, clinical trials showed. That means that one false negative test result could be expected out of every 12 tests.
It was also about 99.98 percent accurate at correctly identifying negative results, a measure known as specificity. That means one false positive would be expected out of every 5,000 test results in uninfected individuals.

OraSure expects the at-home HIV test to be available starting in October at more than 30,000 retail outlets across the U.S. and online.