29 March 2004

by Anai Rhoads

AnaiRhoads.org - Gone are the days of needles and waiting. The Food and Drug Administration (FDA) approved an oral HIV test on 19 March 2004 that promises an accurate alternative to blood sampling.

The OraQuick Rapid HIV-1/2 Antibody Test, manufactured by OraSure Technologies, Inc., was approved 07 November 2002 for detection of antibody to HIV-1 in blood. The test can reliably detect antibodies to HIV-1 and can be stored at room temperature.

"Before the approval of this rapid test in November, 2002, many people being tested for HIV in public clinics did not return for the results of standard tests," said HHS Secretary Tommy G. Thompson. "Where the rapid test is available, those tested get their results within minutes. This oral test provides another important option for people who might be afraid of a blood test. It will improve care for these people and improve the public health as well."

In under twenty minutes the patient can get his or her results without the added anxiety of a blood draw. The device has an exposed pad on one end that absorbs a sample of saliva from the upper and lower row of teeth. One swipe over the gums is all that is needed. A vial with a special solution is included for the patient to put the pad into. If HIV-1 antibodies are present, two reddish-purple lines will appear in the window of the unit.

"I strongly urge the OraSure company to apply for a CLIA waiver for this test using oral fluid samples as well," said Acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D. "If the FDA finds that the companys data proves that the OraQuick test used with oral fluids is both easy and safe to use in the waived lab setting - as it is with used with blood - then more people will likely be tested for HIV infection. In addition, any risk to healthcare workers of performing the test will be greatly reduced since they will not be exposed to blood."

The Centers for Disease Control and Prevention (CDC) estimates that as much as one fourth of the 900,000 people infected by HIV in the United States are not fully aware that they are infected. There are still misconceptions about HIV/AIDS which have led to further cases from unknowing carriers.

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