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3/26/2004

FDA Approves Oral Rapid HIV Antibody Test

Donna Young

The Food and Drug Administration (FDA) today approved the first rapid HIV diagnostic test kit that uses oral fluid specimens rather than blood samples and provides screening results at the patient's point of care in about 20 minutes.

The OraQuick Rapid HIV-1 Antibody Test for use on oral fluid samples correctly identified at least 99.3 percent of specimens from HIV-1-infected persons, and correctly identified at least 99.8 percent of specimens from those people who were not infected, said Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, at a press conference in Washington, D.C.

"About 850,000 to 950,000 Americans are now currently living with HIV, and a quarter of those individuals don't even know that they are infected," said Department of Health and Human Services Secretary Tommy G. Thompson. "That means that more than 225,000 of our fellow Americans don't know that they have this life-threatening viral infection—an infection that they may unwittingly pass on to others."

Until now, he said, all rapid HIV diagnostic tests required people to give a small blood sample by pinprick.

The ability to use oral fluid specimens for HIV-infection testing, Goodman said, "means that another barrier to testing has been removed for those individuals reluctant to be tested due to the need to obtain blood."

The product is manufactured by OraSure Technologies, Inc., a medical diagnostics firm in Bethlehem, Pa.

OraSure's rapid HIV antibody test for use on blood samples was approved in November 2002 for the detection of antibody to HIV-1, and just last Friday, it was approved to detect HIV-2—a variant of HIV that is prevalent in parts of Africa but rarely found in the United States, according to FDA.

But, Thompson noted, OraSure's rapid HIV antibody test for use on oral fluids has been approved only to test for HIV-1.

Many people who go to public clinics for HIV testing do not return to learn the results, Thompson said.

"Each year, 30 percent of HIV-infected people that have taken HIV tests do not return to get their test results," he said. "The OraQuick test [for use on oral fluid samples] will almost certainly reduce that number because it is so fast and is noninvasive."

Because the rapid HIV diagnostic test for use on oral fluids does not involve obtaining or handling a patient's blood, it will "greatly reduce the risk" of exposure to HIV infection for health care workers, Thompson affirmed.

The health secretary demonstrated use of the test at the press conference.

The person performing the test, Thompson said, swabs the upper and lower gums using the device. The tester then takes the device and inserts it into a vial containing a solution.

The test device, he said, "reveals the presence of HIV antibodies by displaying two reddish purple lines in a small window on the device."

However, Goodman said, as with all screening tests for HIV, if a patient's test result is positive for HIV, confirmatory testing is necessary.

The OraQuick Rapid HIV-1/2 Antibody test for use on blood was categorized as a waived test under the Clinical Laboratory Improvements Amendments of 1988, or CLIA, in January, 2003, Goodman said.

A waived test system can be used in facilities with any level of CLIA certificatification, rather than only in facilities certified for higher complexity tests, according to FDA, and can be used in many more health care settings by many different health providers.

For now, Goodman said, the use of the OraQuick test for oral fluids is limited to use by laboratories qualified to perform moderate complexity tests under CLIA.

"I strongly urge the OraSure company to apply to our department for a CLIA waiver for this test using oral swabs," Thompson said. "Then the test can be given in many more heath care settings and perhaps even administered by social workers in HIV counseling centers."