By Shane McGinley
Product will allow for customers in Middle East to test for virus in comfort of own home
Gulf residents may soon be able to order a self-administered, in-home HIV test, which gives a result within 20 to 40 minutes, when the US-produced device goes on-sale online in October.
US health regulators at the Food and Drug Administration gave the green light for the OraQuick In-Home HIV Test, which within 20 to 40 minutes provides results from an oral fluid sample taken by swabbing the upper and lower gums inside the mouth.
The device is already approved for use by trained technicians but will go on-sale in more than 30,000 retailers from October.
While the price has not been disclosed, it is predicted to be slightly higher than the US$17.50 charged for professional use.
The company hopes to eventually expand the availability of its home HIV test to other countries, said Douglas Michels, CEO of Pennsylvania-based pharmaceutical producer OraSure Technologies.
An OraSure spokesperson told Arabian Business “the product is approved only for sale and use in the US,” but confirmed it will be available for sale online from October.
She added that “OraSure has been evaluating opportunities outside the US for the product,” but said that “no definitive plans have been finalised at this time [to distribute OraQuick in stores in the Middle East].”
The FDA cautioned that a positive result from the OraQuick test does not mean an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the result.
About 1.2m people in the US are living with HIV infection, but one in five are not aware of it, according to estimates from the US Centers for Disease Control and Prevention.
An FDA advisory committee of outside experts voted unanimously in favour of the test in May, saying its ability to prevent new HIV infections and link people to medical care and social services outweighed the risk of false results.
Clinical trials for the test showed it was accurate 92 percent of the time in diagnosing people who had HIV - meaning one out of every 12 test results would be a false negative.
The company hopes to eventually expand the availability of its home HIV test to other countries, the CEO said.