CompletedNot Applicable

A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test

United States519 participantsStarted 2008-07

Plain-language summary

This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests to diagnose common vaginal infections.

Who can participate

Age range15 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least 15 years of age at time of enrollment * Ability to provide written informed consent Exclusion Criteria: * Currently menstruating or bleeding * Use of an antibiotic to treat bacterial vaginosis or Trichomonas within the past 7 days

What they're measuring

Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women

Timeframe: Visit 1

Trial details

NCT IDNCT00682851

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2009-04

Results submitted2011-07-08

View on ClinicalTrials.gov More Bacterial Vaginosis trials