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

Inclusion Criteria

• •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 14 years or older who are willing and able to provide written, informed consent; for pediatric participants, written assent and parent/legal guardian consent, as applicable by the institutional review board/ethics committee (IRB/EC).
• •Apparently healthy participants aged 14 years or older who are willing and able to provide written, informed consent; for pediatric participants, written assent and parent/legal guardian consent, as applicable by the IRB/EC.
• •Use of any azole-containing antimicrobial (oral or vaginal) within the 7 days prior to study enrollment.
• •Prior enrollment in this study.
• •Use of any lubricants (eg, Replens, RepHresh) within 3 days prior to sample collection
• •Use of douches, vaginal deodorizers, or other intravaginal products within 3 days prior to sample collection. The use of tampons or pads during menses should not be considered exclusionary criteria.
• •Contraindication to vaginal swab sampling.
• •Asymptomatic participants who do not have any signs or symptoms consistent with vaginitis, vaginosis, or both, as described above.