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Approval of a New Rapid Test for HIV Antibody
JAMA. 2002;288:2960.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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MMWR. 2002;51:1051-1052
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 . . . [Full Text of this Article]
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