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.
Study Type
OBSERVATIONAL
Enrollment
1,000
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.
Segal Trials
North Miami, Florida, United States
RECRUITINGLSU-CrescentCare Sexual Health Center
New Orleans, Louisiana, United States
RECRUITINGAccuracy of Nanopath Assay for Diagnosis of Vaginal Infections
Compare the sensitivity and specificity of the Nanopath assay to NAAT and yeast culture for diagnosing vaginitis
Time frame: 1 day
Equivalency of Percent Agreement Between Self-Collected and Clinician-Collected Samples Using the Nanopath Assay
Compare the performance between clinician-collected samples and self-collected samples using the Nanopath assay for diagnosing vaginitis.
Time frame: 1 day
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