FDA Approves 20-minute HIV Test

The U.S. Food and Drug Administration approved a quick HIV test on Thursday that reduces the waiting period for results from two weeks to 20 minutes.

The agency said the new test should reduce the number of people (approximately 8,000 per year) who test positive but never return to hear the result.

The new OraQuick test will be administered by health workers, who will take a small blood sample from a subject's finger, put it in a vial with a developing solution and then dip in a testing stick. A single red line on the stick means no HIV; two red lines indicate the person may have HIV and should be retested.

A version of the test that uses saliva instead of blood has yet to be approved.

The test is easy enough for social workers to administer, but for now only health workers are authorized because the manufacturer, OraSure Technologies Inc. has not yet applied for the necessary federal approval. According to the Associated Press, Health and Human Services Secretary Tommy Thompson has urged OraSure to take that step so the test can be more widely available.

Redge Norton, spokesman for the San Francisco AIDS Foundation, welcomed the test's approval, saying, "We believe that by removing testing barriers -- and studies show that time is a barrier to some -- people learn their serostatus, make informed health and treatment decisions, and can prevent further transmission."

Shana Krochmal, communications director at San Francisco's Stop AIDS Project, agreed that OraQuick will be an important tool but cautioned that knowing one's HIV status is just part of the picture.

"Any form of testing needs to be paired with solid pre- and post-test counseling that helps people stay safe and healthy by keeping them up-to-date about safer sex and resources for treatment education," she said.

The Centers for Disease Control and Prevention estimates that more than 200,000 people in the United States are infected with HIV but don't know it.

Shipments of OraQuick to distributor Abbott Laboratories are expected to begin in the next 30 to 60 days, OraSure said on Thursday.