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First received: May 09, 2025

Clinical Trial: Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Bacterial Vaginosis

Study Type: OBSERVATIONAL


Official Title: Cobas® BV/CV Test for Use on the Cobas® 5800/6800/8800 Systems: Clinical Performance and Reproducibility

Brief Summary: In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500 symptomatic individuals with a clinical presentation consistent with vaginitis, vaginosis, or both.Additionally, a minimum of 100 asymptomatic individuals will also be enrolled in the study.The cobas® BV/CV assay amplifies and detects the deoxyribonucleic acid (DNA) of pathogens associated…

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