Quick, Simple AIDS Test Is Near Approval

Rapid HIV tests, which give results in two to 20 minutes, are widely used in Europe and dozens of other countries. Their use in the United States, however, has been stalled, first because of patent issues, then accuracy concerns, and finally by disagreement over whether people other than health professionals should be allowed to perform them.

In the past two years, patent issues were largely resolved. Accuracy concerns faded after experiments showed some rapid tests to be nearly 100 percent accurate and in many cases better than tests currently on the market, said Nelson Michael, chief of diagnostics at the Walter Reed Army Institute of Research in Rockville, Md., where such tests were evaluated for military use.

The US Food and Drug Administration in May gave "approvable" letters to two companies -- OraSure Technologies of Bethlehem, Pa., for its OraQuick test, and Canadian-based MedMira Inc. for its test, Reveal -- meaning they are considered safe and effective and eligible for approval, pending plant inspection and agreements on labeling. The final issue -- who could give the tests -- appeared to be resolved after CDC officials held a two-day meeting on the issue last month, where the consensus was that the tests are so simple and accurate that special training is not needed to do them.

"It was a sea change" in attitude toward allowing such tests to be exempt from the Clinical Laboratory Improvements Amendments of 1988 -- regulations Congress passed to ensure that qualified labs perform medical tests, Michael said. FDA officials now "are strongly leaning toward approving OraQuick this month as a CLIA-waived test," he said. The test, which uses a drop of blood from a finger prick, is not likely to be sold over the counter. Instead, the FDA is expected to require that outreach workers get a certificate from the state to offer it to ensure that appropriate counseling and treatment information are given to those who test positive. Raising the number of people who are aware they are infected is one of the CDC's goals in its Serostatus Approach to Fighting the HIV Epidemic (SAFE).

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