US FDA approves first oral fluid based rapid HIV test kit

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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.

Klein

HIV/AIDS Program Director

Office of Special Health Issues

Food and Drug Administration

FDA-HIV-AIDS@...