Bacterial Vaginosis, Candida Vaginitis
Conditions
Brief summary
In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500 symptomatic individuals with a clinical presentation consistent with vaginitis, vaginosis, or both. Additionally, a minimum of 100 asymptomatic individuals will also be enrolled in the study. The cobas® BV/CV assay amplifies and detects the deoxyribonucleic acid (DNA) of pathogens associated with bacterial vaginosis (BV) and candida vaginitis (CV). The BV results will be compared with the patient infection status (PIS) established by using 3 Food and Drug Administration (FDA)-cleared commercial assays, and the CV results will be compared with the PIS established with the use of culture plus MALDI-TOF (matrix-assisted laser desorption/ionization time-of-flight). The primary objective of the clinical performance study is to evaluate the performance (sensitivity and specificity) of cobas® BV/CV to determine the presence of BV and/or CV in the intended use patient population when being tested on cobas® 6800/8800 systems. The secondary objective is to evaluate the equivalency of cobas® BV/CV between the cobas® 5800 system and cobas® 6800/8800 systems.
Interventions
DIAGNOSTIC_TESTcobas® BV/CV test
The cobas® BV/CV test is an automated, qualitative in vitro real-time PCR diagnostic test that detects bacteria and yeast associated with bacterial vaginosis (BV) and candida vaginitis (CV), respectively. The test does not distinguish among the pathogens but can give an overall qualitative result indicating the presence or absence of pathogen(s) associated with BV and/or CV.
DIAGNOSTIC_TESTBD Max™ Vaginal Panel
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three comparators in this study for determining BV patient infection status.
DIAGNOSTIC_TESTCepheid Xpert Xpress MVP
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three comparators in this study for determining BV patient infection status.
DIAGNOSTIC_TESTHologic Aptima BV Assay
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three comparators in this study for determining BV patient infection status.
Sponsors
Roche Molecular Systems
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for Symptomatic Participants: * Symptomatic participants with a clinical presentation consistent with vaginitis, vaginosis, or both; symptoms may include abnormal vaginal discharge, painful or frequent urination, vaginal itching or burning or irritation, painful or uncomfortable intercourse, and/or abnormal vaginal odor. * Participants aged 14 years or older who are willing and able to provide written, informed consent; for pediatric participants, written assent and parent/legal guardian consent, as applicable by the institutional review board/ethics committee (IRB/EC). Inclusion Criteria for Asymptomatic Participants: * Apparently healthy participants aged 14 years or older who are willing and able to provide written, informed consent; for pediatric participants, written assent and parent/legal guardian consent, as applicable by the IRB/EC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Sensitivity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status | Day 1 | The sensitivity of a diagnostic test is the percentage of true positive (TP) tests out of all patients with a condition. It is calculated as follows: 100% x (TP)/(TP + false negatives (FN)). The BV test results will be compared with the patient infection status (PIS) established by using 3 Food and Drug Administration (FDA)-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF. |
| Clinical Specificity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status | Day 1 | The specificity of a diagnostic test is the percentage of true negative (TN) tests out of all patients who do not have a condition. It is calculated as follows: 100% x (TN)/(TN + false positives (FP)). The BV test results will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF. |
| Positive Predictive Value of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status | Day 1 | The positive predictive value of a diagnostic test is the percentage of true positive (TP) tests out of all of the positive findings. It is calculated as follows: 100% x (TP)/(TP + FP). The BV test results will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF. |
| Negative Predictive Value of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status | Day 1 | The negative predictive value of a diagnostic test is the percentage of true negative (TN) tests out of all of the negative findings. It is calculated as follows: 100% x (TN)/(TN + FN). The BV test results will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Equivalency of the cobas® 5800 System and the cobas® 6800/8800 Systems: Clinical Sensitivity of the cobas® BV/CV Test for Detecting the Presence of BV and/or CV | Day 1 | The sensitivity of a diagnostic test is the percentage of true positive (TP) tests out of all patients with a condition. It is calculated as follows: 100% x (TP)/(TP + false negatives (FN)). The BV test results obtained with each cobas® system will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results obtained with each cobas® system will be compared with the PIS established by using selective culture and MALDI-TOF. |
| Equivalency Between the cobas® 5800 System and the cobas® 6800/8800 Systems: Clinical Specificity of the cobas® BV/CV Test for Detecting the Presence of BV and/or CV | Day 1 | The specificity of a diagnostic test is the percentage of true negative (TN) tests out of all patients who do not have a condition. It is calculated as follows: 100% x (TN)/(TN + false positives (FP)). The BV test results obtained with each cobas® system will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results obtained with each cobas® system will be compared with the PIS established by using selective culture and MALDI-TOF. |
Countries
Bulgaria, Switzerland, United States
Outcome results
None listed