Which rapid HIV screening tests are approved by the FDA for use in the US?

Updated: Mar 05, 2020
  • Author: Delia M Rivera, MD; Chief Editor: Russell W Steele, MD  more...
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Answer

The US Food and Drug Administration (FDA) has approved 4 rapid HIV screening tests that are available commercially in the United States, as listed below. Before the FDA approved these tests, the most commonly used rapid HIV test was the Single-Use Diagnostic System (Murex SUDS; Abbott Diagnostics, Abbott Park, IL), which is no longer available.

  • OraQuick (and its newer version OraQuick Advance) Rapid HIV-1/2 Antibody Test (OraSure Technologies, Inc, Bethlehem, PA)

  • Reveal G3 Rapid HIV-1 Antibody Test (MedMira Laboratories, Inc, Halifax, Nova Scotia, Canada)

  • Uni-Gold Recombigen HIV Test (Trinity Biotech, Bray, Ireland)

  • Multispot HIV-1/HIV-2 Rapid Test (Bio-Rad Laboratories, Redmond, WA)


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