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

NCT00682851 | Completed Results

• 1 other identifier: PRO08020012
• Study Type: observational
• Target: 519
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacterial Vaginosis; Urogenital Infection by Trichomonas Vaginalis

Outcome Measures

Primary Outcomes (1)

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

  Sensitivity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.

  Visit 1

Secondary Outcomes (3)

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

  Visit 1

• Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.

  Visit 1

• Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.

  Visit 1

Interventions

OSOM Trichomonas Rapid Test DEVICE

Rapid test run using vaginal discharge collected via a cotton swab

OSOM BVBlue Test DEVICE

Rapid test run using vaginal discharge collected using a cotton swab

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-pregnant women between the ages of 18 and 60, with or without symptoms of vaginitis, were recruited for this study from Magee-Womens Hospital of University of Pittsburgh Medical Center and Allegheny County Health Department.

You may qualify if:

• At least 15 years of age at time of enrollment
• Ability to provide written informed consent

You may not qualify if:

• Currently menstruating or bleeding
• Use of an antibiotic to treat bacterial vaginosis or Trichomonas within the past 7 days

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

A major limitation of this study was that in the first 122 women, 24% of the cohort, the vaginal swabs used for the diagnostic tests were collected in random order, which resulted in decreased sensitivity of the OSOM Rapid and BVBLue tests.

Results Point of Contact

• Title: Lorna Rabe
• Organization: Magee-Womens Research Institute

lrabe@mwri.magee.edu

412-641-6042

Study Officials

• Sharon L Hillier, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 22, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 22, 2016
• Results First Posted: August 8, 2011

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)