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
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®
be stored at room temperature and requires
no specialized equipment.
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How the Oral Test Works
The "lateral-flow" technology behind
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.