FDA APPROVES ORAL RAPID HIV TEST

TEST PROVIDES RESULTS IN 20 MINUTES

March 28, 2004, Los Angeles, CA – With the approval of the first oral rapid HIV test, the Food and Drug Administration (FDA) has provided a vital new weapon for HIV prevention in the United States, AIDS Project Los Angeles (APLA) said today.

The OraQuick HIV-1/2 test, which is more than 99 percent accurate, provides results in 20 minutes and obviates the need for a blood sample. The original version of this rapid test was approved November 7, 2002 for detection of antibody to HIV-1 in blood.

“Approval of the OraQuick Rapid Antibody test kits using oral fluid samples may be one of the biggest HIV stories of 2004,” said APLA executive director Craig E. Thompson. “This much anticipated addition to available options for HIV antibody testing means we have a truly convenient, non-invasive and rapid test.”

All new test systems are grouped under CLIA (Clinical Laboratory Improvements Amendments of 1988) as high complexity systems until they are submitted for categorization under CLIA. Product sponsors may apply for a waiver for this test, which allows the test to be used in health care settings beyond those approved and administered under CLIA.

“AIDS Project Los Angeles hopes that a CLIA waiver will be secured soon,” said Thompson, “so that implementation of this test kit will be swifter and smoother than with the blood-based version of this technology.”

AIDS Project Los Angeles, one of the nation’s largest AIDS service organizations, provides direct services to more than 10,000 men, women and children living with HIV or AIDS in Los Angeles County each year. Services include prevention education, food banks and nutrition education, professional dental care, housing assistance, transportation, mental health counseling, case management and home health care. APLA is a leader in the provision of bilingual HIV treatment information, in print and on the Internet, and advocates for effective AIDS-related policies and legislation on the local, state and federal level. For more information, please visit www.apla.org.

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