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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

Study Description
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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.

Condition or disease Intervention/treatment
Bacterial Vaginosis Urogenital Infection by Trichomonas Vaginalis Device: OSOM Trichomonas Rapid Test Device: OSOM BVBlue Test

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 Design
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Study Type : Observational
Actual Enrollment : 519 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
Study Start Date : July 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009
Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682851


Locations
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United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Sharon L Hillier, PhD University of Pittsburgh
More Information
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Responsible Party: Sharon Hillier, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00682851    
Other Study ID Numbers: PRO08020012
First Posted: May 22, 2008    Key Record Dates
Results First Posted: August 8, 2011
Last Update Posted: September 22, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Trichomonas Infections
Vaginal Diseases
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Vaginitis
Protozoan Infections
Parasitic Diseases