US approves 1st rapid, take-home HIV test (Update)

July 3, 2012 by MATTHEW PERRONE
In this undated handout photo provided by Orasure a model demonstrates the OraQuick test, which detects the presence of HIV in saliva collected using a mouth swab. The test is designed to return a result within 20 to 40 minutes. The U.S. Food and Drug Administration approved the first over-the-counter HIV test Tuesday, July 3, 2012, allowing Americans to check themselves for the virus that causes AIDS in the privacy of their homes. (AP Photo/Orasure, Chuck Zovko)

The U.S. Food and Drug Administration has approved the first over-the-counter HIV test, allowing Americans to check themselves for the virus that causes AIDS in the privacy of their homes.

The OraQuick test detects the presence of HIV in saliva collected using a mouth swab. The test is designed to return a result within 20 to 40 minutes.

Government officials estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware they are infected. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.

FDA officials said the test is aimed at people who might not otherwise get tested. The company's marketing efforts will focus on populations at greatest risk of being infected, including gay and bisexual men, African Americans and Hispanics.

HIV awareness groups hailed the approval as an important step in expanding testing for the virus.

"This test will allow anyone to empower themselves to know their HIV status when, how and with whom they want to," said Tom Donohue, founding director of Who's Positive.

This undated handout photo provided by Orasure shows the OraQuick test, which detects the presence of HIV in saliva collected using a mouth swab. The test is designed to return a result within 20 to 40 minutes. The U.S. Food and Drug Administration approved the first over-the-counter HIV test Tuesday, July 3, 2012, allowing Americans to check themselves for the virus that causes AIDS in the privacy of their homes. (AP Photo/Orasure, Chuck Zovko)

HIV eventually develops into AIDS, unless treated with antiviral drugs. AIDS causes the body's immune system to break down, leading to infections which become fatal.

The FDA previously approved several HIV test kits designed to be used at home, although those kits — which usually require a blood sample — must be sent to a laboratory to be developed.

FDA stressed in its approval announcement that the test is not 100 percent accurate.

A trial conducted by Orasure showed the home test correctly detected HIV in those carrying the virus only 92 percent of the time. That means the test could miss one person for every 12 HIV-infected people who use the kit.

The test was accurate 99 percent in ruling out HIV in patients not carrying the virus. That means the test would incorrectly identify one patient as having HIV for every 5,000 HIV-negative people tested.

People who test negative should get re-tested after three months because it can take several weeks for detectable antibodies to HIV to appear, according to Dr. Jonathan Mermin, director of the Centers for Disease Control and Prevention's HIV unit.

Orasure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2002. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 percent of the time.

While it's not clear why the test appears less accurate in consumer trials, company researchers said they expected the test's specificity to drop when used by consumers versus professionals.

Orasure plans to launch the test in October, selling it through retailers like Walgreens, CVS and Walmart, as well as online pharmacies. Whereas the test marketed to health professionals costs about $17.50, Orasure expects the consumer version to sell for more. The company is not announcing a price yet, but said it would be less than $60. CEO Doug Michels said the additional cost will help pay for a toll-free call center to provide counseling and medical referrals to test users.

Shares of Orasure Technologies rose 59 cents, or 5 percent, to $12.09.

Explore further: FDA reviews first rapid, take-home test for HIV

shares

Related Stories

FDA reviews first rapid, take-home test for HIV

May 11, 2012
The Food and Drug Administration is considering approval of the first over-the-counter HIV test that would allow consumers to quickly test themselves for the virus at home, without medical supervision.

FDA panel backs first rapid, take home HIV test

May 15, 2012
(AP) -- A panel of HIV specialists is recommending that U.S. regulators approve the first over-the-counter HIV test designed to quickly return a result in the privacy of a person's own home, a new option which could expand ...

US trying out free rapid AIDS test at drugstores

June 26, 2012
(AP) — U.S. health officials have set up a $1.2 million pilot program to that will offer free rapid HIV tests at pharmacies and in-store clinics in 24 cities and rural communities in hopes that testing for the AIDS virus ...

Recommended for you

Scientists divulge latest in HIV prevention

July 25, 2017
A far cry from the 1990s "ABC" campaign promoting abstinence and monogamy as HIV protection, scientists reported on new approaches Tuesday allowing people to have all the safe sex they want.

Girl's HIV infection seems under control without AIDS drugs

July 24, 2017
A South African girl born with the AIDS virus has kept her infection suppressed for more than eight years after stopping anti-HIV medicines—more evidence that early treatment can occasionally cause a long remission that, ...

Meds by monthly injection might revolutionize HIV care (Update)

July 24, 2017
Getting a shot of medication to control HIV every month or two instead of having to take pills every day could transform the way the virus is kept at bay.

Candidate AIDS vaccine passes early test

July 24, 2017
The three-decade-old quest for an AIDS vaccine received a shot of hope Monday when developers announced that a prototype triggered the immune system in an early phase of human trials.

Paris spotlight on latest in AIDS science

July 21, 2017
Some 6,000 HIV experts gather in Paris from Sunday to report advances in AIDS science as fading hopes of finding a cure push research into new fields.

Scientists elicit broadly neutralizing antibodies to HIV in calves

July 20, 2017
Scientists supported by the National Institutes of Health have achieved a significant step forward, eliciting broadly neutralizing antibodies (bNAbs) to HIV by immunizing calves. The findings offer insights for HIV vaccine ...

1 comment

Adjust slider to filter visible comments by rank

Display comments: newest first

concered17
not rated yet Jul 09, 2012
"The test was accurate 99 percent in ruling out HIV in patients not carrying the virus. That means the test would incorrectly identify one patient as having HIV for every 5,000 HIV-negative people tested." Whence the 50x increased accuracy?? 1 in 5,000 would mean 99.98% accuracy or not?!

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.