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

Description

In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500 symptomatic individuals with a clinical presentation consistent with vaginitis, vaginosis, or both. Additionally, a minimum of 100 asymptomatic individuals will also be enrolled in the study. The cobas® BV/CV assay amplifies and detects the deoxyribonucleic acid (DNA) of pathogens associated with bacterial vaginosis (BV) and candida vaginitis (CV). The BV results will be compared with the patient infection status (PIS) established by using 3 Food and Drug Administration (FDA)-cleared commercial assays, and the CV results will be compared with the PIS established with the use of culture plus MALDI-TOF (matrix-assisted laser desorption/ionization time-of-flight). The primary objective of the clinical performance study is to evaluate the performance (sensitivity and specificity) of cobas® BV/CV to determine the presence of BV and/or CV in the intended use patient population when being tested on cobas® 6800/8800 systems. The secondary objective is to evaluate the equivalency of cobas® BV/CV between the cobas® 5800 system and cobas® 6800/8800 systems.

Conditions

Bacterial Vaginosis, Candida Vaginitis

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Study Overview

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Study Details

Study overview

In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500 symptomatic individuals with a clinical presentation consistent with vaginitis, vaginosis, or both. Additionally, a minimum of 100 asymptomatic individuals will also be enrolled in the study. The cobas® BV/CV assay amplifies and detects the deoxyribonucleic acid (DNA) of pathogens associated with bacterial vaginosis (BV) and candida vaginitis (CV). The BV results will be compared with the patient infection status (PIS) established by using 3 Food and Drug Administration (FDA)-cleared commercial assays, and the CV results will be compared with the PIS established with the use of culture plus MALDI-TOF (matrix-assisted laser desorption/ionization time-of-flight). The primary objective of the clinical performance study is to evaluate the performance (sensitivity and specificity) of cobas® BV/CV to determine the presence of BV and/or CV in the intended use patient population when being tested on cobas® 6800/8800 systems. The secondary objective is to evaluate the equivalency of cobas® BV/CV between the cobas® 5800 system and cobas® 6800/8800 systems.

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

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

Condition
Bacterial Vaginosis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Matrix Clinical Research, Los Angeles, California, United States, 90057-4103

San Diego

M3 Wake Research - San Diego at Convoy, San Diego, California, United States, 92111

Lakewood

Red Rocks OBGYN, Lakewood, Colorado, United States, 80228

Lake Worth

Altus Research, Lake Worth, Florida, United States, 33461

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

New Bern

Eastern Carolina Women's Center, New Bern, North Carolina, United States, 28562

Winston-Salem

Unified Women's Clinical Research/Lyndhurst, Winston-Salem, North Carolina, United States, 27103

Houston

Planned Parenthood Gulf Coast, Houston, Texas, United States, 77023

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * 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.

Ages Eligible for Study

14 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2025-06-30