Nanopath, Inc
In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay. The Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.
This is an observational, diagnostic study.
Inclusion Criteria: Biologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis: * Abnormal vaginal discharge * Vaginal or vulvar itching, burning, or irritation * Painful or uncomfortable intercourse * Vaginal odor * Painful or frequent urination Exclusion Criteria: * Participants who do not meet the above-described inclusion criteria will be excluded from the study. * Previously enrolled in this study * Contraindication to vaginal swab sampling
Investigational Device
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation.