N/A
Completed N=519
A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
Bacterial vaginosis · Urogenital Infection by Trichomonas Vaginalis
Source: ClinicalTrials.gov NCT00682851 ↗
Enrolled (actual)
519
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.