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FDA Approves 20-minute HIV Test

The government approved a new 20-minute HIV test on Thursday that promises to let more Americans than ever before learn on-the-spot if they're infected with the AIDS virus.

It's not the first rapid HIV test: a 10-minute version has been sold since the mid-1990s, but was so difficult to use accurately that many health clinics abandoned it. Most of today's routine HIV tests take days to provide results - and at least 8,000 people a year who test positive at public testing clinics never return to get the news.

Federal AIDS experts called the new OraQuick test so easy to use that it should dramatically cut that number, helping thousands more people learn they're infected so they can seek treatment - and quit spreading the disease.

To use OraQuick, a health worker simply pricks a person's finger, puts a spot of blood into a vial containing a developing solution, and then dips in the sticklike testing device. Reading the results is similar to reading common pregnancy tests: A single reddish line on the OraQuick dipstick means no HIV. Two reddish lines means the person may be infected and needs a confirmatory test to be sure.

The test detects antibodies to HIV, and scientific studies show it provides results with 99.6 percent accuracy, the Food and Drug Administration said in announcing Thursday's approval.

 An easy rapid test has long been in demand: The military wants one simple enough for battlefield use. Obstetricians want to test women in labor who don't know their HIV status so that babies of infected mothers can get immediate treatment that might keep them healthy. Hospitals want a fast way to tell whether health workers exposed to blood from HIV-infected patients need to be given anti-HIV medication.

 And AIDS activists say a rapid test easy enough for use by social workers instead of health workers would be a boon to increasing the availability of HIV testing, particularly in inner cities or poor rural areas where access to health clinics is limited.

OraQuick may indeed prove that easy, but for now it can be offered only by certified health workers because of a legal hitch, Health and Human Service Secretary Tommy Thompson said Thursday.

The law requires that some types of medical tests be given only by health workers certified in certain laboratory standards - unless the test's manufacturer requests and receives a federal waiver allowing use with less stringent oversight.

Manufacturer OraSure Technologies Inc. has not yet asked for that waiver, but Thompson publicly urged the company to take that step so OraQuick could be offered more broadly. The Centers for Disease Control and Prevention estimates that between 850,000 and 950,000 Americans have HIV, and a quarter of them don't know it.

(China Daily November 8, 2002)  

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