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Oral HIV Test Failure

There are concerns tonight surrounding a widely used HIV test’s accuracy. There are reports it incorrectly diagnoses many as having HIV, when they in fact don’t.

“With something like 40,000 new infections in the United States every year, and almost a third of those people that are infected not knowing their HIV status it is really important for us to reach those people that are not testing,” argues Drew De Los Reyes of Gay Men’s Health Crisis in New York.

Part of the problem is, the HIV test is a scary, nerve-wracking test to take.

So it’s crucial that any HIV test be as accurate as possible.

This test—oraquick--is used by many public health clinics and other organizations to test for the aids virus, in large part because you can get results back within twenty to thirty minutes, helping allay some of the fears of the wait.

“That is a huge difference, historically people have had to wait some times a week, maybe two weeks before they would get their results back, so this is really addressing a need that has been out there for a long time,” says De Los Reyes.

Oraquick is on deck to be approved for at home use by the FDA…
But this past week, it hit a stumbling block.

In both San Francisco and New York, the number of tests that were positive--but incorrectly positive--suddenly jumped.

In New York alone, these false positive tests shot up six times.

The maker of oraquick, orasure, says, “the company is approaching this particular situation in a very scientific and systematic order to determine what might be causing these discordant results at these particular sites and will resolve any issues that might exist.”

Verifying the test’s accuracy is key given it has spurred on more testing, especially in at risk populations. “We have seen a market increase in the number of people that have been coming in. A little more than 95% of our clients choosing the rapid test over the week long waiting period from the standard tests,” says De Los Reyes.

In November of 2005, the centers for disease control and prevention presented data on oraquick advance showing 99.8 percent of the time, if the person is hiv negative, it will read as negative.

“Nothing is a hundred percent accurate especially if we are taking about a screening test,” De Los Reyes argues.

But the concern is the nerve-wracking part; what it was intended to help relieve it may actually be causing in the end if indeed there are now more false positive results than expected.