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Vaginal Diseases clinical trials

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NCT ID: NCT02558179 Enrolling by invitation - Clinical trials for Vaginosis, Bacterial

Diagnosing Bacterial Vaginosis/Vaginitis (BV) Using the Gynecologene Test Method

SAGE
Start date: September 2015
Phase: N/A
Study type: Observational [Patient Registry]

This study is designed as a prospective evaluation of the diagnostic performance of the multiplex nucleic acid-based genetic test (Gynecologene Next-Generation Sequencing test) to identify known significant causative organisms in bacterial vaginosis/vaginitis and other major pathogens and normal commensals in symptomatic women during the reproductive years. Vaginal fluid samples will be split and tested with the comparator methods and Nugent score, with the results evaluated according to sensitivity, specificity, positive predictive value, and negative predictive value. Laboratorians performing each test will be blinded to the clinical history and any prior test results to minimize ascertainment bias. Each subject will be followed routinely for up to 6 weeks after initial visit for vaginosis/vaginitis by telephone or office visit at the discretion of the treating physician.