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U.S. Department of Health and Human Services

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3 issues related to Rapid Testing for HIV

1. FDA APPROVES FIRST ORAL FLUID BASED RAPID HIV TEST KIT - OraQuick Rapid HIV-1 Antibody Test

FDA today (March 26, 2004) approved the use of oral fluid samples with a rapid HIV diagnostic test kit that correctly identified 99.3 of specimens from infected people (sensitivity) and 99.8% of specimens from uninfected people (specificity) in limited studies provided by the manufacturer in support of this approval. The test provides the result in approximately 20 minutes.

In addition to simplifying the testing process, precluding the need for a blood sample, use of the oral collection component reduces risk to healthcare workers performing the test by reducing exposure to blood and sharps.

The original version of this rapid test - the OraQuick Rapid HIV-1 Antibody Test, manufactured by OraSure Technologies, Inc., Bethlehem, PA - was approved November 7, 2002 for detection of antibody to HIV-1 in blood.

The test can quickly and reliably detect antibodies to HIV-1, can be stored at room temperature and requires no specialized equipment.

The device has an exposed absorbent pad at one end which is gently swabbed around the mouth between the teeth and the outer gums. It is then inserted into a vial containing a solution. In as little as 20 minutes, the test device will indicate whether HIV-1 antibodies are present in the solution by displaying either one bar (the control indicator, showing a negative HIV response) or two bars (the control plus reactive test indicator) in a small window on the device. Two bars indicate a presumptive positive result, requiring a Western Blot test to confirm HIV infection.

The rapid test is not approved or intended for home use and has not been approved to screen blood donors.

All new test systems are categorized under CLIA (Clinical Laboratory Improvements Amendments of 1988) as high complexity systems until they are submitted for categorization under CLIA. The product sponsor may apply for a waiver for this test. Without a CLIA waiver, tests can only be administered in CLIA-approved labs by CLIA-certified laboratory technicians or medical staff. CLIA waiver allows the test to be used in many more health care settings.

The OraQuick Rapid HIV-1 antibody test was granted a CLIA waiver in January, 2003 for use with whole blood specimens only.

2. HIV-1/2 IN PLASMA

Also on March 26, 2004, the OraQuick Rapid HIV-1 Antibody Test was approved for testing plasma for HIV-1 and HIV-2 (a variant of HIV that is prevalent in parts of Africa but rarely found in the United States).

3. HIV-2 IN WHOLE BLOOD

On March 19, 2004, FDA approved the OraSure rapid test for detection of HIV-2 when used with a whole blood sample. The rapid test kit is identical to the earlier approved version. However, subsequent data submitted to the agency has demonstrated its ability to detect HIV-2.

When used with oral fluid the test is approved only to detect antibodies only to HIV-1.

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration