Trial Outcomes & Findings for A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test (NCT NCT00682851)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

519 participants

Primary outcome timeframe

Visit 1

Results posted on

2016-09-22

Participant Flow

Participant milestones

Participant milestones
Measure	Symptomatic 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.	Asymptomatic 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 Study STARTED	251	268
Overall Study COMPLETED	251	268
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Symptomatic n=251 Participants 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.	Asymptomatic n=268 Participants 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 n=519 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	239 Participants n=5 Participants	252 Participants n=7 Participants	491 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.3 years STANDARD_DEVIATION 8.2 • n=5 Participants	27.0 years STANDARD_DEVIATION 8.7 • n=7 Participants	27.6 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	251 Participants n=5 Participants	268 Participants n=7 Participants	519 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	251 participants n=5 Participants	268 participants n=7 Participants	519 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Symptomatic n=251 Participants 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.	Asymptomatic n=268 Participants 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).
Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women OSOM Rapid Test	92 Percentage of Participants Interval 78.0 to 98.0	91 Percentage of Participants Interval 72.0 to 99.0
Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women PCR	100 Percentage of Participants Interval 90.0 to 100.0	100 Percentage of Participants Interval 85.0 to 100.0
Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women Wet Mount Microscopy	58 Percentage of Participants Interval 41.0 to 74.0	48 Percentage of Participants Interval 27.0 to 69.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Symptomatic n=251 Participants 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.	Asymptomatic n=268 Participants 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).
Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women OSOM Rapid Test	99 Percentage of Participants Interval 97.0 to 100.0	99 Percentage of Participants Interval 97.0 to 100.0
Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women PCR	96 Percentage of Participants Interval 92.0 to 98.0	96 Percentage of Participants Interval 92.0 to 98.0
Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women Wet Mount Microscopy	99 Percentage of Participants Interval 97.0 to 100.0	100 Percentage of Participants Interval 99.0 to 100.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Symptomatic n=251 Participants 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.	Asymptomatic n=268 Participants 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).
Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women. BVBlue Test	68 Percentage of Participants Interval 60.0 to 76.0	61 Percentage of Participants Interval 51.0 to 71.0
Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women. Amsel Criteria	82 Percentage of Participants Interval 75.0 to 88.0	67 Percentage of Participants Interval 57.0 to 76.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Symptomatic n=251 Participants 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.	Asymptomatic n=268 Participants 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).
Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women. BVBlue Test	100 Percentage of Participants Interval 96.0 to 100.0	99 Percentage of Participants Interval 96.0 to 100.0
Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women. Amsel Criteria	94 Percentage of Participants Interval 87.0 to 98.0	100 Percentage of Participants Interval 98.0 to 100.0

Adverse Events

Symptomatic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Asymptomatic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lorna Rabe

Magee-Womens Research Institute

Phone: 412-641-6042

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place