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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00682851
First received: May 16, 2008
Last updated: August 25, 2011
Last verified: August 2011
  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 (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.


Condition Intervention
Bacterial Vaginosis
Urogenital Infection by Trichomonas Vaginalis
Device: OSOM Trichomonas Rapid Test
Device: OSOM BVBlue Test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 BV in Symptomatic and Asymptomatic Women. [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
    Sensitivity 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 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 ] [ Designated as safety issue: No ]
    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
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00682851     History of Changes
Other Study ID Numbers: PRO08020012
Study First Received: May 16, 2008
Results First Received: July 8, 2011
Last Updated: August 25, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vaginosis, Bacterial
Trichomonas Infections
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 16, 2014