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…
Read more