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FDA granted a CLIA (Clinical Laboratory Improvements Amendments
of 1988] waiver to the OraQuick ADVANCE Rapid HIV-1/2 Antibody
Test for use with oral fluid on June 25,
2004.
The OraQuick ADVANCE
Rapid HIV Test is a fast and non-invasive test approved on March 26, 2004, to detect
antibodies to HIV-1 in oral
fluid. The oral fluid indication was extended by FDA to include detection of antibodies to
HIV-2 in oral fluid on June 22, 2004.
Originally,
use of OraQuick ADVANCE Rapid HIV
test to detect antibodies
to HIV in oral fluid had
been limited to certified laboratories (high and moderate complexity
laboratories under CLIA). However, as a result of the waiver from
the requirements of CLIA, all clinical
laboratories certified through CLIA (high, moderate, and waived) can
now use this test. The CLIA waiver allows the test to be used under less
stringent controls, which is expected to have a major impact on increased
access to HIV testing.
The CLIA
waiver will allow the rapid oral fluid
test to be used in more health care settings, such as doctors’ offices,
clinics, and some mobile labs that can offer testing in high-risk areas. Through
these venues, testing will be
accessible to many more people, particularly to those
individuals who are reluctant to be tested due to the need to draw
blood.
The test
is expected to help diagnose
more people earlier, improving their treatment
options, and reducing their chance
of infecting others. It will also protect health care workers from
infection by reducing their
exposure to blood.
Manufacturers must
submit a request for a
CLIA waiver to FDA. To qualify for a waiver, a test must be
simple, accurate and present no reasonable risk of harm.
FDA based its
waiver decision for the OraQuick
ADVANCE Rapid HIV Test on information submitted by the
manufacturer, OraSure Technologies, Inc., Bethlehem, PA, demonstrating that the test is simple to run, is
very robust under a wide range of environmental stresses, and generates highly
accurate results in a wide variety of settings.
The OraQuick ADVANCE Rapid HIV-1/2 Antibody
Test provides a highly accurate HIV
test result from an easily collected oral fluid sample in as little as 20
minutes, without the need to draw blood. According to data submitted by
OraSure and reviewed by the FDA, in limited clinical studies the OraQuick
correctly identified at least 99.3% of specimens from HIV-infected persons and
at least 99.8% of specimens from uninfected persons.
A reactive result using the OraQuick Rapid HIV-1/2
Antibody Test with oral fluid is considered a preliminary positive result and
must be confirmed using an additional, more specific test, such as the Western Blot, just as for testing
using blood samples.
Richard
Klein
HIV/AIDS Program
Director
Food and Drug
Administration
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