Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,082
- 试验地点
- 4
- 主要终点
- Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness
研究概览
简要总结
The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's instructions by personnel in laboratories holding Clinical Laboratory Improvement Amendments (CLIA) waivers (or equivalent) on nasopharyngeal swab samples obtained from volunteers with signs and/or symptoms of a respiratory infection. The study data will be used to support an application to the FDA for CLIA-waived categorization of FilmArray RP EZ. It is hypothesized that the results of the FilmArray RP EZ test performed in a laboratory with CLIA waiver with be 95% accurate when compared to FilmArray RP testing performed in a lab with a moderate or high complexity CLIA certification.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Displays signs and/or symptoms of respiratory infections
- •Adult patients must provide informed consent
- •Parental consent for children (<18)
排除标准
- •Adult patients unable to provide informed consent
- •Children that are currently in foster care, or are wards of the state
结局指标
主要结局
Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness
时间窗: 1.5 hour
In general, performance of the FilmArray RP EZ test in the CLIA-waived setting is expected to meet at least 95% positive and negative percent agreement with the results obtained from FilmArray RP in the moderate/high- complexity setting for each pathogen on the panel.
次要结局
- Epidemiology of respiratory infections in a CLIA-waived setting(Up to 9 months)