Bacterial Vaginosis, Urogenital Infection by Trichomonas Vaginalis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOSOM Trichomonas Rapid Test
Rapid test run using vaginal discharge collected via a cotton swab
DEVICEOSOM BVBlue Test
Rapid test run using vaginal discharge collected using a cotton swab
Sponsors
University of Pittsburgh
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women | 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. |
| Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women. | 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. |
| Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 251 |
| 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). | 268 |
| Total | 519 |
Baseline characteristics
| Characteristic | Asymptomatic | Symptomatic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 12 Participants | 28 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 252 Participants | 239 Participants | 491 Participants |
| Age, Continuous | 27.0 years STANDARD_DEVIATION 8.7 | 28.3 years STANDARD_DEVIATION 8.2 | 27.6 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment United States | 268 participants | 251 participants | 519 participants |
| Sex: Female, Male Female | 268 Participants | 251 Participants | 519 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 251 | 0 / 268 |
| serious Total, serious adverse events | 0 / 251 | 0 / 268 |
Outcome results
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.
Time frame: Visit 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Symptomatic | 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 |
| Symptomatic | 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 |
| Symptomatic | 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 |
| Asymptomatic | Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women | OSOM Rapid Test | 91 Percentage of Participants |
| Asymptomatic | 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 |
| Asymptomatic | Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women | Wet Mount Microscopy | 48 Percentage of Participants |
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.
Time frame: Visit 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Symptomatic | Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women. | BVBlue Test | 68 Percentage of Participants |
| Symptomatic | Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women. | Amsel Criteria | 82 Percentage of Participants |
| Asymptomatic | Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women. | BVBlue Test | 61 Percentage of Participants |
| Asymptomatic | Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women. | Amsel Criteria | 67 Percentage of Participants |
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.
Time frame: Visit 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Symptomatic | Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women. | BVBlue Test | 100 Percentage of Participants |
| Symptomatic | Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women. | Amsel Criteria | 94 Percentage of Participants |
| Asymptomatic | Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women. | BVBlue Test | 99 Percentage of Participants |
| Asymptomatic | Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women. | Amsel Criteria | 100 Percentage of Participants |
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.
Time frame: Visit 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Symptomatic | 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 |
| Symptomatic | 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 |
| Symptomatic | 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 |
| Asymptomatic | 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 |
| Asymptomatic | 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 |
| Asymptomatic | Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women | Wet Mount Microscopy | 100 Percentage of Participants |