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

Inclusion Criteria for Symptomatic Participants:

• 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).

Inclusion Criteria for Asymptomatic Participants:

• 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.

Exclusion Criteria for Symptomatic Participants:

• Participants not meeting the above described inclusion criteria will be excluded from the study.
• 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.

Exclusion Criteria for Asymptomatic Participants:

• Prior enrollment in this study.
• 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.