Cobas® BV/CV Test for Use on the Cobas® 5800/6800/8800 Systems: Clinical Performance and Reproducibility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 738
- 试验地点
- 10
- 主要终点
- Clinical Sensitivity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Clinical Sensitivity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
时间窗: Day 1
The sensitivity of a diagnostic test is the percentage of true positive (TP) tests out of all patients with a condition. It is calculated as follows: 100% x (TP)/(TP + false negatives (FN)). The BV test results will be compared with the patient infection status (PIS) established by using 3 Food and Drug Administration (FDA)-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF.
Clinical Specificity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
时间窗: Day 1
The specificity of a diagnostic test is the percentage of true negative (TN) tests out of all patients who do not have a condition. It is calculated as follows: 100% x (TN)/(TN + false positives (FP)). The BV test results will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF.
Positive Predictive Value of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
时间窗: Day 1
The positive predictive value of a diagnostic test is the percentage of true positive (TP) tests out of all of the positive findings. It is calculated as follows: 100% x (TP)/(TP + FP). The BV test results will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF.
Negative Predictive Value of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
时间窗: Day 1
The negative predictive value of a diagnostic test is the percentage of true negative (TN) tests out of all of the negative findings. It is calculated as follows: 100% x (TN)/(TN + FN). The BV test results will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF.
次要结局
- Equivalency of the cobas® 5800 System and the cobas® 6800/8800 Systems: Clinical Sensitivity of the cobas® BV/CV Test for Detecting the Presence of BV and/or CV(Day 1)
- Equivalency Between the cobas® 5800 System and the cobas® 6800/8800 Systems: Clinical Specificity of the cobas® BV/CV Test for Detecting the Presence of BV and/or CV(Day 1)