First home-use HIV test gets USFDA approval
New Delhi: The first over-the-counter HIV test has won the approval of the US Food and Drug Administration, which will allow Americans to test 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 of the 1.2 million HIV carriers in the US 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 FDA said a positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result.
Similarly, a negative test result does not necessarily mean that an individual is not infected with HIV, particularly when exposure may have been within the previous three months.
OraSure Technologies, the manufacturer of the OraQuick In-Home HIV Test will have a consumer support centre that is available through phone and will be open 24 hours a day, seven days a week.
The centre will be operational and available to educate users with information about HIV/AIDS, the proper method for administering the test and guidance on what to do once results have been obtained once the manufacturer makes the product available for sale to the public.
The home test is expected to be available in about 30,000 pharmacies, grocery stores and online retailers by October, OraSure`s chief executive Douglas Michels said.
While the price of the kit has not yet been fixed, Michels said it would be higher than the current USD 17.50 that is charged to medical professionals because the company will do more complicated packaging for the home kit, open a 24-hour question line, and advertise to high-risk groups, including gay men, blacks and Hispanics, and sexually active adults.
The kit will be sold at an affordable rate so that it is accessible for people who might want to buy several a year, Michels added.
The test will however not be 100 per cent accurate.
Clinical studies for self-testing have shown that the OraQuick In-Home HIV Test has an expected performance of 92 per cent for test sensitivity, the percentage of results that will be positive when HIV is present.
In other words, one false negative result would be expected out of every 12 test results in HIV-infected individuals.
Clinical studies also have shown that the OraQuick In-Home HIV Test has an expected performance of 99.98 per cent for test specificity, the percentage of results that will be negative when HIV is not present.
This means that one false positive would be expected out of every 5,000 test results in uninfected individuals.
(With Agencies inputs)