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SAMHSA News - November/December 2004, Volume 12, Number 6

Facts about Rapid HIV Testing


SAMHSA's new Rapid HIV Testing Initiative uses the OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test.

The test kit consists of a single-use test device and a single-use test developer solution. Additional items provided include a reusable test stand and disposable specimen collection loop.

Test results are provided with greater than 99-percent accuracy in as little as 20 minutes.

Other facts about this product include:

  • The OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test is the first and only rapid, point-of-care test approved by the U.S. Food and Drug Administration (FDA).

  • In June 2004, the FDA approved a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for the OraQuick® ADVANCE test.

  • The test is available for use by more than 180,000 sites registered under CLIA in the United States, including hospitals, physicians' offices, health clinics, outreach clinics, HIV counseling centers, and community-based organizations.

  • Unlike other antibody tests for HIV, OraQuick® ADVANCE can be stored at room temperature and requires no specialized equipment.

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How the Oral Test Works

The "lateral-flow" technology behind OraQuick® ADVANCE is similar to that used in a home pregnancy test. For the oral rapid test, oral fluid is collected by gently swabbing completely around the outer gums, both upper and lower, one time around, using the flat pad of the device. Then, the device is inserted into the vial of special solution provided. The result appears on the device as a prominent line, which becomes evident in about 20 minutes.

The national rate of HIV transmission continues to grow, especially in low-income, minority populations, with 40,000 new cases reported each year. Currently, at least 1 million Americans are living with HIV/AIDS.

Helping to increase the number of people who learn their HIV status will ultimately help prevent the spread of HIV and ensure more timely treatment for those infected.

For additional background information on rapid HIV tests, visit www.cdc.gov/hiv/rapid_testing.

For more information about the test, call 1 (800) 869-3538.

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