N/A N=519

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

Bacterial Vaginosis · Urogenital Infection by Trichomonas Vaginalis

Bottom Line

View on ClinicalTrials.gov: NCT00682851 ↗

Enrolled (actual)

519

Serious AEs

0.0%

Results posted

Aug 2011

Primary outcome: Primary: Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women — 92; 91; 100; 100 Percentage of Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: OSOM Trichomonas Rapid Test (Device); OSOM BVBlue Test (Device)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: Female
Sponsor: University of Pittsburgh
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women	92; 91; 100; 100; 58; 48	—
SECONDARY Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women	99; 99; 96; 96; 99; 100	—
SECONDARY Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.	68; 61; 82; 67	—
SECONDARY Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.	100; 99; 94; 100	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00682851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.