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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 Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Conditions Bacterial Vaginosis
Urogenital Infection by Trichomonas Vaginalis
Interventions Device: OSOM Trichomonas Rapid Test
Device: OSOM BVBlue Test
Enrollment 519
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Symptomatic Asymptomatic
Hide Arm/Group Description Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain. Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
Period Title: Overall Study
Started 251 268
Completed 251 268
Not Completed 0 0
Arm/Group Title Symptomatic Asymptomatic Total
Hide Arm/Group Description Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain. Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain). Total of all reporting groups
Overall Number of Baseline Participants 251 268 519
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants 268 participants 519 participants
<=18 years
12
   4.8%
16
   6.0%
28
   5.4%
Between 18 and 65 years
239
  95.2%
252
  94.0%
491
  94.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 251 participants 268 participants 519 participants
28.3  (8.2) 27.0  (8.7) 27.6  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants 268 participants 519 participants
Female
251
 100.0%
268
 100.0%
519
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 251 participants 268 participants 519 participants
251 268 519
1.Primary Outcome
Title Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women
Hide Description 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.
Time Frame Visit 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symptomatic Asymptomatic
Hide Arm/Group Description:
Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
Overall Number of Participants Analyzed 251 268
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
OSOM Rapid Test
92
(78 to 98)
91
(72 to 99)
PCR
100
(90 to 100)
100
(85 to 100)
Wet Mount Microscopy
58
(41 to 74)
48
(27 to 69)
2.Secondary Outcome
Title Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women
Hide Description 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.
Time Frame Visit 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symptomatic Asymptomatic
Hide Arm/Group Description:
Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
Overall Number of Participants Analyzed 251 268
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
OSOM Rapid Test
99
(97 to 100)
99
(97 to 100)
PCR
96
(92 to 98)
96
(92 to 98)
Wet Mount Microscopy
99
(97 to 100)
100
(99 to 100)
3.Secondary Outcome
Title Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.
Hide Description 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.
Time Frame Visit 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symptomatic Asymptomatic
Hide Arm/Group Description:
Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
Overall Number of Participants Analyzed 251 268
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
BVBlue Test
68
(60 to 76)
61
(51 to 71)
Amsel Criteria
82
(75 to 88)
67
(57 to 76)
4.Secondary Outcome
Title Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.
Hide Description 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.
Time Frame Visit 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symptomatic Asymptomatic
Hide Arm/Group Description:
Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
Overall Number of Participants Analyzed 251 268
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
BVBlue Test
100
(96 to 100)
99
(96 to 100)
Amsel Criteria
94
(87 to 98)
100
(98 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symptomatic Asymptomatic
Hide Arm/Group Description Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain. Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
All-Cause Mortality
Symptomatic Asymptomatic
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Symptomatic Asymptomatic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/251 (0.00%)   0/268 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Symptomatic Asymptomatic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/251 (0.00%)   0/268 (0.00%) 
A major limitation of this study was that in the first 122 women, 24% of the cohort, the vaginal swabs used for the diagnostic tests were collected in random order, which resulted in decreased sensitivity of the OSOM Rapid and BVBLue tests.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lorna Rabe
Organization: Magee-Womens Research Institute
Phone: 412-641-6042
EMail: lrabe@mwri.magee.edu
Layout table for additonal information
Responsible Party: Sharon Hillier, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00682851    
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