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

Launched by HOFFMANN-LA ROCHE · May 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the cobas® BV/CV Test, which aims to identify two common vaginal conditions: bacterial vaginosis (BV) and candida vaginitis (CV). The study will involve at least 500 women who have symptoms like unusual vaginal discharge, itching, or discomfort, as well as 100 women who do not have any symptoms. By testing samples collected from these participants, researchers hope to determine how well the cobas® test can accurately detect these conditions compared to other established tests.

To be eligible for the study, women aged 14 and older can participate if they have symptoms consistent with vaginitis or if they are healthy and show no signs of these conditions. Participants will provide vaginal swab samples, which will be collected by a healthcare professional or with their guidance. It's important to note that certain recent treatments or products used in the vagina may exclude someone from participating. Overall, this study aims to improve testing for BV and CV, helping healthcare providers better diagnose and treat these conditions.

Gender

FEMALE

Eligibility criteria

• 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 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:
• 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.