Study to Collect Vaginal Swab Samples for Developing and Testing a New Vaginitis Diagnostic Algorithm Using Nanopath Assay

What this Trial Is About

Researchers are conducting an observational diagnostic study to develop and validate a new algorithm for diagnosing bacterial vaginosis and to evaluate the Nanopath assay, a molecular test that detects pathogens linked to vaginitis. The study focuses on individuals showing signs and symptoms of vaginitis and aims to compare the Nanopath assays performance with FDA-cleared commercial tests and yeast culture methods. Participants will provide vaginal swab specimens collected both by clinicians and by themselves. The study will assess the Nanopath assay, an amplification-free molecular test, alongside three FDA-cleared diagnostic tests BD Max14 Vaginal Panel, Cepheid Xpert4 Xpress MVP, and Hologic Aptima4 BV Assay, as well as yeast culture with MALDI-TOF for species identification. These comparisons will help validate the new diagnostic algorithm. During the study, participants will be asked to provide vaginal swab samples for analysis. Researchers will measure the accuracy of the Nanopath assay in diagnosing vaginal infections and compare the agreement between self-collected and clinician-collected samples. The study will collect data on symptoms and perform laboratory testing to evaluate diagnostic performance, with the primary outcome measured within one day of sample collection. Participants involvement includes sample collection and symptom reporting, with no treatment provided as part of this observational study.

Large Algorithm Setting and Validation Study