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Notice to Readers: Approval of a New Rapid Test for HIV Antibody
On November 7, 2002, the Food and Drug Administration announced approval of the OraQuick Rapid HIV-1 Antibody Test (OraSure Technologies, Inc., Bethlehem, Pennsylvania) for use by trained personnel as a point-of-care test to aid in the diagnosis of infection with human immunodeficiency virus type 1 (HIV-1). OraQuick is a simple, rapid test that can detect antibodies to HIV in fingerstick whole blood specimens and provide results in <20 minutes. The test has been categorized as moderate complexity under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). A second FDA-approved moderate-complexity rapid HIV test, Single Use Diagnostic System for HIV-1(Abbott-Murex Inc., Norcross, Georgia), remains available in the United States for use with serum or plasma specimens.
Use of a rapid test that allows same-day results can substantially increase the number of persons who receive their test results, which improves the delivery of counseling and treatment services (1). On the basis of data submitted by the manufacturer for test approval, the sensitivity* of OraQuick in the clinical studies performed was 99.6% (95% confidence interval [CI]=98.5%--99.9%), and specificity was 100% (95% CI=99.7%--100%), comparable to those of FDA-approved enzyme immunoassays in widespread use. Because HIV prevalence is low in most U.S. testing settings, the negative predictive value of screening with a single rapid test is high. Therefore, a negative rapid HIV test does not require further testing, and negative results with counseling can be provided at the initial visit. Retesting is recommended for those persons with a recent (within 3 months) history of known or possible exposure to HIV because there might have been insufficient time for detectable antibodies to develop (2). As with any HIV screening test, all reactive (preliminary positive) rapid test results should be confirmed by supplemental testing by either a Western blot or immunofluorescence assay (3). The confirmatory tests can be performed on serum specimens obtained by phlebotomy, dried blot spots obtained on filter paper, or oral fluid specimens collected with the OraSure collection device.
Persons whose rapid-test results are reactive should be counseled about their likelihood of being infected with HIV and precautions to prevent HIV transmission, but they should return for definitive test results before medical referrals or partner counseling is initiated (3). A simple message to convey this information could be a statement that "Your preliminary test result was positive, but we won't know for sure if you are HIV-infected until we get the results from your confirmatory test. In the meantime, you should take precautions to avoid possibly transmitting the virus."
The Public Health Service recommends that rapid HIV tests should be used and preliminary positive test results provided when tested persons might benefit (1). Decisions about whether to use rapid tests should be based on considerations of return rates for standard test results and urgency of the need for test results (i.e., when necessary to make decisions about postexposure or perinatal prophylaxis) (1,4,5). The use of rapid tests will facilitate the acceptance of HIV testing and improve receipt of results in other health-care settings in which HIV testing is recommended, such as hospitals and acute-care clinics, where persons who are unaware of their HIV status might seek health-care services (6). Additional information and guidance on the use of rapid HIV tests are available from CDC at http://www.cdc.gov/hiv/testing.htm.
Sites wanting to perform this new HIV-1 rapid test that are not already certified to perform moderate-complexity laboratory tests under CLIA must enroll in the CLIA program, administered by the Centers for Medicare and Medicaid Services. The application and state agency contact information are available at http://www.cms.hhs.gov/clia. Information about enrollment and the requirements for moderate-complexity testing are available at http://www.phppo.cdc.gov/clia/default.asp.
CLIA moderate-complexity requirements provide minimum standards for personnel, quality control, proficiency testing, and quality assurance. In addition, some states have specific requirements that might apply to laboratory testing in general or to HIV testing specifically.
* Sensitivity is the probability that the test result will be reactive if the specimen is a true positive; specificity is the probability that the test result will be nonreactive if the specimen is a true negative.
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This page last reviewed 11/21/2002