A new method for testing HIV, that can be done in privacy at home, sold over-the-counter and returns results in 20 minutes could soon be approved by the Food and Drug Administration.
Though currently there are other at-home methods of testing HIV, they still require the extraction of blood by the consumer in order to be tested at a lab. The new over-the-counter HIV test created by Orasure Technologies, based on Bethlehem, Pennsylvania, and currently awaiting FDA approval, uses an oral swap, instead of a blood sample, to deliver a result in 20 minutes, instead of days. An advisory panel of 17 members has already endorsed the new HIV test before the FDA. The motives for the advisory panel to endorse the test have been that, even considering that the test is not infallible, it has a documented window of error of the 7% of the cases, an at-home counter HIV test represents more benefits than the possibles risks of a fail negative.
This can be of significant importance in the fight against HIV and AIDS, given the benefit it would be having a reliable and affordable method for consumers to test themselves in only 20 minutes and in the privacy of their homes. The test is already use on clinical environment testing, and it awaits for the approval of the FDA for its over-the-counter sale to general consumers. Though there is no information yet on what might be the retail price to consumers for the HIV test, the current price for its clinical use is $17,50
Given the known fact that the AIDS virus is pass from partner to partner via sexual contact, it can be spread without knowledge of contagion, which makes a counter more private test a way to encourage regular testing for risks sectors of the population. Estimations are that about a quarter of a million of the people currently infected with the AIDS virus from the 1.2 million carriers in US is not aware of the fact is infected, and the rate of new infections in US for the last 20 years has been a steady 50 thousand people infected per year. The counter HIV test has been proven to give a correct positive identification of the virus for a 93% of the cases, which means, in an scenario on which subjects are tested in regular bases, it could successfully diagnose 45 thousand of the new infected, and according to FDA’s estimations it could prevent about 4 thousand new infected per year.
An at-home over-the-counter test could help guarantee the privacy and discretion needed for such a sensitive matter and encourage a more constant testing. Studies have shown that the majority of gay and bisexual men, one of the sectors of the population in more risk, would undergo frequent testing for HIV, if they could find a private and discrete way to do it.
Even with the panel’s endorsement and clinical trials in its favor, Orasure’s 20 minutes HIV test still needs to pass the FDA approval process. The results of that process would be presented further this year.