HHS Extends Use of Rapid Oral HIV Test to New Sites Nationwide
Date: June 25, 2004
Contact: FDA Press Office
(301) 827-6242
SAMHSA Press Office
(301) 443-8956
HHS Will Fund Use of Rapid Test For Injection Drug User Community
HHS Secretary Tommy G. Thompson today announced that HHS has extended the
availability of a recently approved rapid oral HIV test from the current
38,000 laboratories permitted to perform the test to more than 100,000
sites, including physician offices, HIV counseling centers and community
health centers. In addition, the Secretary announced that HHS would fund a
$4.8 million effort to add the rapid test to Department-funded programs to
reduce HIV/AIDS among injection drug users.
"These actions will expand even further the availability of a simple, rapid
HIV test to communities where people are at high risk of HIV," Secretary
Thompson said. "HIV testing has never been easier or more accessible than it
is today. As we prepare to mark National HIV Testing Day on Sunday, I urge
anyone who thinks they may be at risk for HIV to get tested and know your
status."
The OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test, manufactured by OraSure
Technologies, Inc., of Bethlehem, Pa., provides results in as little as 20
minutes. To perform the oral test, the person being tested for HIV-1/2
takes the device, which has an exposed absorbent pad at one end, and places
the pad above the teeth and against the outer gum. The person then gently
swabs completely around the outer gums, both upper and lower, one time
around. The device is then inserted into a vial containing a solution. The
test device will indicate with more than 99 percent accuracy if HIV-1/2
antibodies are present in the solution by displaying two reddish-purple
lines in a small window on the device.
HHS granted the expanded availability of the test under a Clinical
Laboratory Improvement Amendments (CLIA) waiver. Manufacturers can request a
CLIA waiver that allows the test to be used under less stringent controls.
CLIA-waived tests can be performed and interpreted in a physician's office
or other settings without having to be sent out to a CLIA-certified
laboratory. To qualify for a waiver, a test must be simple, accurate and
present no reasonable risk of harm.
HHS' Food and Drug Administration (FDA) approved OraQuick in November 2002
for use as a blood test in laboratories that perform moderate complexity
testing, and in January 2003, HHS categorized the rapid blood test as a
waived test under CLIA. The oral version of the test was approved by FDA in
March 2004.
Secretary Thompson also announced that $4.8 million has been allocated to
HHS' Substance Abuse and Mental Health Administration (SAMHSA) from the
National Minority AIDS Initiative Secretariat fund to support new
demonstrations for rapid HIV test technologies. This includes both testing
kits and, critically, the training to support their proper use. SAMHSA will
incorporate rapid HIV testing into its programs for reducing the spread of
HIV/AIDS among injection drug users and their sex partners, who represent
one-third of persons infected with HIV in the U.S.
Each year, 8,000 HIV-infected people who come to public clinics for HIV
testing do not return a week later to receive their test results. With the
new rapid HIV test, individuals need only give a drop of blood or a swab of
saliva, and the results are available on the spot in about 20 minutes. As
with all screening tests for HIV, if the OraQuick gives a reactive test
result, that result must be confirmed with an additional specific test.
Widespread availability of the rapid oral version of the HIV test will
likely further increase overall HIV testing and decrease the number of
people -- an estimated 225,000 Americans -- who are unaware they are
infected with the HIV virus. Early testing enables infected individuals to
obtain medical care earlier in the course of their infection, potentially
saving lives and limiting the spread of this deadly virus.