The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Samples with Matching Results
研究概览
简要总结
The purpose of this study is for the research team to become familiar with and evaluate the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer by testing 120 archived specimens that were previously tested at the Wisconsin State Laboratory of Hygiene (WSLH) by RT-PCR and multiplex respiratory pathogen panel within the last year.
详细描述
To test the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer, the investigator proposes to test samples archived from the ORegon CHild Absenteeism due to Respiratory Disease Study (ORCHARDS) study (HSC 2013-1357), a study that had the goal to "develop and implement a system for daily school-based monitoring of ILI (influenza-like illness) and CLI (COVID-like illness) student absenteeism in kindergarten (K) through grade 12 schools, and assess the system's usability for early detection of accelerated influenza, SARS-CoV-2 and other respiratory pathogen transmission in schools and surrounding communities".
The deidentified paired (WSLH vs. Savanna RVP4) results will be used by QuidelOrtho Corporation to evaluate the technical and operational performance of the analyzer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously collected specimens from the ORCHARDS study.
排除标准
- •Specimens not collected as part of the ORCHARDS study.
结局指标
主要结局
Number of Samples with Matching Results
时间窗: up to 6 months
There were a number of viruses detected in the ORCHARDS study \[Ad, adenovirus; CoV, coronavirus; Flu, influenza virus; hMPV, human metapneumovirus; PIV, parainfluenza virus; R/E, rhinovirus/enterovirus; RSV, respiratory syncytial virus\]. Reported here are the number of samples for which the Savanna RVP4 results match the WSLH results.
次要结局
未报告次要终点