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Supplemental Testing for Confirmation of Reactive Oral Fluid Rapid
HIV Antibody Tests
On December 16, this report was posted as an
MMWR Dispatch on the MMWR website
(http://www.cdc.gov/mmwr).
In March 2004, the Food and Drug Administration (FDA) approved the
OraQuick® Rapid HIV-1 Antibody Test
(OraSure Technologies, Bethlehem, Pennsylvania) for use with oral fluid by trained personnel as a point-of-care test to aid in the
diagnosis of infection with human immunodeficiency
virus (HIV). In June 2004, FDA approved an added claim for detection of
HIV-2 antibodies in oral fluid and a change in the name of the
device to OraQuick® Advance Rapid HIV-1/2 Antibody Test.
A reactive rapid HIV test result is considered preliminary and must be confirmed by supplemental testing
(1). Some false positive rapid test results (i.e., reactive rapid test results followed by negative supplemental test results) are to be
expected within the range of specificity for the device. However, in late 2005, HIV testing programs in multiple U.S. cities experienced apparent clusters of
false-positive rapid HIV test results using oral fluid (but not whole blood) specimens. Counselors at these programs have expressed
concern regarding the specificity and positive predictive value of the oral fluid rapid HIV test. The published sensitivity and specificity for the
test using oral fluid are 99.3% (95% confidence interval [CI] = 98.4%--99.7%) and 99.8% (CI = 99.6%--99.9%), respectively. CDC
has received multiple inquiries concerning whether its guidelines for confirmatory testing for reactive rapid HIV tests on oral fluid
specimens have been modified.
CDC is actively working with FDA, state and local health officials, and the product manufacturer to investigate these
reports, assess the test's current performance, and consider whether changes in testing protocols should be recommended or any
other actions taken. In the meantime, current protocols for confirmation of reactive rapid HIV test results should continue to
be followed (2). These protocols ensure that clients with reactive rapid test results receive accurate HIV test results
after confirmation. HIV counselors returning reactive (preliminary positive) results from HIV rapid tests to clients should provide
the same counseling message that is currently recommended
(3), regardless of whether the reactive test
result was obtained using oral fluid or whole blood. HIV testing program directors who have noted any problems or who have concerns over the
performance
of the OraQuick Advance Rapid HIV-1/2 Antibody Test in their particular settings should report these concerns to
OraSure Technologies at telephone 800-672-7873.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of
Health and Human Services.References to non-CDC sites on the Internet are
provided as a service to MMWR readers and do not constitute or imply
endorsement of these organizations or their programs by CDC or the U.S.
Department of Health and Human Services. CDC is not responsible for the content
of pages found at these sites. URL addresses listed in MMWR were current as of
the date of publication.
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