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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00682851
First Posted: May 22, 2008
Last Update Posted: September 22, 2016
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.
Information provided by (Responsible Party):
Sharon Hillier, University of Pittsburgh
  Purpose
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 Intervention
Bacterial Vaginosis Urogenital Infection by Trichomonas Vaginalis Device: OSOM Trichomonas Rapid Test Device: OSOM BVBlue Test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test

Further study details as provided by Sharon Hillier, University of Pittsburgh:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 519
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
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
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
United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sharon L Hillier, PhD University of Pittsburgh
  More Information

Responsible Party: Sharon Hillier, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00682851     History of Changes
Other Study ID Numbers: PRO08020012
First Submitted: May 16, 2008
First Posted: May 22, 2008
Results First Submitted: July 8, 2011
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:
Vaginosis, Bacterial
Trichomonas Infections
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Protozoan Infections
Parasitic Diseases