HHS has extended the availability of a recently approved rapid oral HIV test

Jun 26 2004

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.

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