FDA approves 20 minute take-home HIV test
The FDA has approved an over-the-counter HIV that takes just 20 minutes
One of the biggest problems in fighting the spread of AIDS has always
been convincing people to have themselves tested regularly.
Unfortunately, getting someone to take a trip to a clinic isn't always
easy, particularly in areas where there aren't many options for discrete
testing. In a development that could leap right over this privacy
hurdle, the U.S. Food and Drug Administration has just unanimously
approved an over-the-counter HIV test that enables people to test
themselves in their own home and receive results in just 20 minutes.
The company behind the test, Orasure, has been distributing its
OraQuick HIV test to doctors and medical facilities since 2004. With the
stamp of approval from the FDA though, the same test could be as easy
for consumers to obtain and use as a pregnancy test. There have been
take-home HIV tests before, but those have involved mailing a blood
sample off to a lab and then waiting several days for results.
By approving the test - which uses an easier and faster testing
method - the FDA hopes to appeal to a much broader range of potential
customers and help people determine whether they are HIV-positive much
sooner. With government officials estimating that as much as 240,000
people in the U.S. alone do not realize they are infected, a test like
this could be a huge step towards slowing the spread of the disease.
When used by medical professionals, the test has shown to be accurate
99% of the time, but a trial conducted by Orasure found that this
accuracy dropped to 93% when used by average consumers. After
deliberating with a panel of experts, the FDA decided the benefits of
the test far outweighed this drawback. Panelists who spoke with the FDA
also stressed the importance of clearly stating on the test's packaging
that a negative result does not necessarily mean a person is HIV-free.
Orasure has not revealed how much the OraQuick HIV test will cost
once it appears in stores, but the professional version is currently
priced at US$17.50.
Source: Orasure via New York Times
