A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
NCT ID: NCT00682851
Last Updated: 2016-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
519 participants
OBSERVATIONAL
2008-07-31
2009-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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OSOM Trichomonas Rapid Test
Rapid test run using vaginal discharge collected via a cotton swab
OSOM BVBlue Test
Rapid test run using vaginal discharge collected using a cotton swab
Eligibility Criteria
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Inclusion Criteria
* Ability to provide written informed consent
Exclusion Criteria
* Use of an antibiotic to treat bacterial vaginosis or Trichomonas within the past 7 days
15 Years
FEMALE
Yes
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Sharon Hillier
PhD
Principal Investigators
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Sharon L Hillier, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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PRO08020012
Identifier Type: -
Identifier Source: org_study_id
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