Which tests have been FDA-approved for diagnosing trichomoniasis?

Updated: Jan 02, 2020
  • Author: Darvin Scott Smith, MD, MSc, DTM&H; Chief Editor: Michael Stuart Bronze, MD  more...
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Answer

The following six FDA-approved molecular tests are currently available for diagnosing trichomoniasis in women:

  • Affirm VPIII Microbial Identification Test (a DNA probe; BD Diagnostic Systems, Sparks, Maryland)
  • APTIMA T vaginalis assay (a nucleic acid hybridization test, Hologic Gen-Probe, San Diego, California)
  • BD ProbeTec TV Qx Amplified DNA Assay (a DNA probe, Becton Dickinson, Franklin Lakes, New Jersey)
  • OSOM Trichomonas Rapid Test (an antigen-based test; Genzyme Diagnostics, Cambridge, Massachusetts)
  • Solana Trichomonas Assay (a DNA probe, Quidel, San Diego, California)
  • Xpert TV Assay (a DNA probe, Cepheid, Sunnyvale, California)

All the above tests have a sensitivity greater than 83% (except for the Affirm VPIII, at 63%) and a specificity greater than 97% for detecting T vaginalis in vaginal secretions. Of the above tests, only Xpert TV has been FDA-approved for the diagnosis of trichomoniasis in men. [78] However, according to the CDC, APTIMA may also be used with male urine or urethral swabs from men. [11]


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