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

May 16, 2008
August 25, 2011
July 2008
April 2009   (final data collection date for primary outcome measure)
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.
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00682851 on ClinicalTrials.gov Archive Site
  • 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.
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Bacterial Vaginosis
  • Urogenital Infection by Trichomonas Vaginalis
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
519
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Female
15 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00682851
PRO08020012
No
University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Sharon L Hillier, PhD University of Pittsburgh
University of Pittsburgh
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP