The Bush administration said Friday it will permit wider use of an oral test for the AIDS virus that gives results in 20 minutes. The relaxed rules will allow screenings in HIV counseling centers, community health centers and doctors' offices.
In addition, the government will spend almost $5 million to augment testing of intravenous drug users.
"HIV testing has never been easier or more accessible than it is today," Health and Human Services Secretary Tommy Thompson said, announcing the changes in advance of National HIV Testing Day on Sunday.
In March, the government approved the OraQuick test for use mainly in hospitals and large health clinics. The test is manufactured by OraSure Technologies Inc. in 38,000 laboratories and, unlike other tests, does not require blood. With OraQuick, a technician wipes a treated cotton swab along the gums, picking up not saliva but cells lining the mouth.
The swab is placed in a vial, and infection is signaled by the presence of reddish-purple lines in a window on the vial. OraQuick also makes a rapid blood test.
About one-fourth of the 850,000 to 950,000 Americans living with HIV don't know it, according to the Centers for Disease Control and Prevention.
The rapid blood test was praised when it won approval in November 2002 as a way to increase dramatically the number of people aware of their infections. Until then, routine HIV tests took up to two weeks to provide results, and 8,000 people a year who tested positive at public clinics never returned to get the news.
The rapid oral test may further expand efforts to get more high-risk people tested, because some people shun blood tests and because needle-free testing is safer for health workers, too.
Both rapid tests are more than 99 percent accurate, the FDA said, but people who test positive will have an additional laboratory-run test to reconfirm HIV infection.
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On the Net:
Food and Drug Administration: http://www.fda.gov/
OraSure Technologies Inc.: http://www.orasure.com/
