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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00682851
Recruitment Status : Completed
First Posted : May 22, 2008
Results First Posted : August 8, 2011
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
Sharon Hillier, University of Pittsburgh

Tracking Information
First Submitted Date May 16, 2008
First Posted Date May 22, 2008
Results First Submitted Date July 8, 2011
Results First Posted Date August 8, 2011
Last Update Posted Date September 22, 2016
Study Start Date July 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 25, 2011)
Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women [ Time Frame: Visit 1 ]
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.
Original Primary Outcome Measures
 (submitted: May 21, 2008)
To compare the sensitivity and specificity of the OSOM Test to wet mount microscopy, Trichomonas culture, and PCR in diagnosing Trichomonas vaginalis [ Time Frame: Visit 1 ]
Change History
Current Secondary Outcome Measures
 (submitted: August 15, 2016)
  • Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women [ Time Frame: Visit 1 ]
    Specificity 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 specificity of a test is the percentage of people who do not have the infection (as diagnosed using the gold standard method) among those who have a negative test.
  • Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women. [ Time Frame: Visit 1 ]
    Sensitivity of the BVBlue Test and Amsel criteria in diagnosing bacterial vaginosis using Gram Stain (Nugent scoring) 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.
  • Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women. [ Time Frame: Visit 1 ]
    Specificity of the BVBlue Test and Amsel criteria in diagnosing BV using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed by the gold standard method) among those who have a negative test.
Original Secondary Outcome Measures
 (submitted: May 21, 2008)
To compare the sensitivity and specificity of the BVBlue Test to Amsel criteria and Gram Stain (Nuget scoring) in diagnosing BV. [ Time Frame: Visit 1 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
Official Title A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
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.
Detailed Description

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 (that take up to 7 days to get results) to diagnose common vaginal infections (Trichomonas and bacterial vaginosis).

Both rapid tests (OSOM and BVBlue) are approved by the Food and Drug Administration (FDA) to be used by healthcare professionals to aid in the diagnosis of these infections. This study is being done to validate (or confirm)the accuracy of these tests. This study may help researchers decide if these tests could be used in remote research settings (in place of the standard office testing) to increase diagnosis and prompt treatment of these vaginal infections.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Bacterial Vaginosis
  • Urogenital Infection by Trichomonas Vaginalis
Intervention
  • Device: OSOM Trichomonas Rapid Test
    Rapid test run using vaginal discharge collected via a cotton swab
  • Device: OSOM BVBlue Test
    Rapid test run using vaginal discharge collected using a cotton swab
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 8, 2011)
519
Original Estimated Enrollment
 (submitted: May 21, 2008)
500
Actual Study Completion Date April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00682851
Other Study ID Numbers PRO08020012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sharon Hillier, University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators Not Provided
Investigators
Principal Investigator: Sharon L Hillier, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date August 2016