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

Inclusion Criteria:

Inclusion Criteria for Symptomatic Participants:

• Symptomatic participants with a clinical presentation consistent with vaginitis,vaginosis, or both; symptoms may include abnormal vaginal discharge, painful orfrequent urination, vaginal itching or burning or irritation, painful oruncomfortable 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/legalguardian 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 toprovide written, informed consent; for pediatric participants, written assent andparent/legal guardian consent, as applicable by the IRB/EC.

Exclusion Criteria:

Exclusion Criteria for Symptomatic Participants:

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

• Use of any azole-containing antimicrobial (oral or vaginal) within the 7 days priorto study enrollment.

• Prior enrollment in this study.

• Use of any lubricants (eg, Replens, RepHresh) within 3 days prior to samplecollection

• Use of douches, vaginal deodorizers, or other intravaginal products within 3 daysprior to sample collection. The use of tampons or pads during menses should not beconsidered exclusionary criteria.

• Contraindication to vaginal swab sampling.

• Asymptomatic participants who do not have any signs or symptoms consistent withvaginitis, 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, orboth; symptoms may include abnormal vaginal discharge, painful or frequenturination, vaginal itching or burning or irritation, painful or uncomfortableintercourse, and/or abnormal vaginal odor.