Large Algorithm Setting and Validation Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Nanopath Vaginitis Assay: Investigational Device

BD Max™ Vaginal Panel: 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.

Cepheid Xpert® Xpress MVP: 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.

Hologic Aptima® BV Assay: 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.

Yeast Culture: Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections — 1 day
  Compare the sensitivity and specificity of the Nanopath assay to NAAT and yeast culture for diagnosing vaginitis

Trial sites (2)

Other trials for the same condition