cobas® BV/CV Test for Use on cobas® 5800/6800/8800 Systems: Clinical Performance and Reproducibility

Criteria for participation in trial
• Symptomatic participants with a clinical presentation consistent with vaginitis, vaginosis, or both. Symptoms may include abnormal vaginal discharge, painful or frequent urination, vaginal itching or burning or irritation, painful or uncomfortable intercourse, and/or abnormal vaginal odor. • Participants aged 18 years and older who are willing and able to provide written informed consent. (BASEC)

Exclusion criteria
• Use of an azole-containing antibiotic (oral or vaginal) within 7 days prior to enrollment in the study. • Previous enrollment in this study. • Use of lubricants (e.g., Replens, RepHresh) within 3 days prior to sample collection. • Use of douches, vaginal deodorants, or other intravaginal products within 3 days prior to sample collection. Use of tampons or pads during menstruation should not be considered exclusion criteria. • Contraindication for vaginal swab collection. • Asymptomatic participants who do not exhibit signs or symptoms indicative of vaginitis, vaginosis, or both, as described above. (BASEC)