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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 to diagnose common vaginal infections.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSOM Trichomonas Rapid Test | Device | Rapid test run using vaginal discharge collected via a cotton swab | ||
| OSOM BVBlue Test | Device | Rapid test run using vaginal discharge collected using a cotton swab |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women | 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. | Visit 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Non-pregnant women between the ages of 18 and 60, with or without symptoms of vaginitis, were recruited for this study from Magee-Womens Hospital of University of Pittsburgh Medical Center and Allegheny County Health Department.
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| Name | Affiliation | Role |
|---|---|---|
| Sharon L Hillier, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Asymptomatic |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Visit 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lorna Rabe | Magee-Womens Research Institute | 412-641-6042 | lrabe@mwri.magee.edu |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| Visit 1 |
| Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women. | 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. | Visit 1 |
| Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women. | 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. | Visit 1 |
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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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). |
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| Secondary | Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Visit 1 |
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| Secondary | Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Visit 1 |
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| Secondary | Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Visit 1 |
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| 0 |
| 251 |
| 0 |
| 251 |
| EG001 | 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). | 0 | 268 | 0 | 268 |
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| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Wet Mount Microscopy |
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