A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
研究概览
简要总结
In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay.
The Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.
详细描述
This is an observational, diagnostic study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis:
- •Abnormal vaginal discharge
- •Vaginal or vulvar itching, burning, or irritation
- •Painful or uncomfortable intercourse
- •Vaginal odor
- •Painful or frequent urination
排除标准
- •Participants who do not meet the above-described inclusion criteria will be excluded from the study.
- •Previously enrolled in this study
- •Contraindication to vaginal swab sampling
研究组 & 干预措施
Vaginal Infections (BV, CV, TV)
干预措施: Nanopath Vaginitis Assay (Diagnostic Test)
Vaginal Infections (BV, CV, TV)
干预措施: BD Max™ Vaginal Panel (Diagnostic Test)
Vaginal Infections (BV, CV, TV)
干预措施: Cepheid Xpert® Xpress MVP (Diagnostic Test)
Vaginal Infections (BV, CV, TV)
干预措施: Hologic Aptima® BV Assay (Diagnostic Test)
Vaginal Infections (BV, CV, TV)
干预措施: Yeast Culture (Diagnostic Test)