An Observational, Prospective and Retrospective Clinical Study to Evaluate the Performance of QIAstat-Dx® Gastrointestinal Panel 2 During Normal Conditions of Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Clinical sensitivity
研究概览
简要总结
Performance evaluation of QIAstat-Dx® GI2 Panel using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx® GI2 Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment
详细描述
The objective of the study is to demonstrate that the QIAstat-Dx® Gastrointestinal Panel 2 achieves its intended performance during normal conditions of use by the intended user in the intended environment.
The primary objective is to evaluate the performance of QIAstat-Dx® GI2 Panel in comparison with the results obtained from the reference methods.
The secondary objective of the study is to evaluate the safety of QIAstat-Dx® GI2 Panel with respect to users/operators.
The primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® GI2 Panel and Reference Method(s). Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stool specimen must have been collected from subjects/patients which meet the institute's criteria for a suspected enteric pathogen, such as individuals presenting with symptoms of gastrointestinal infection;
- •Stool specimen will be residual and obtained for completion of routine gastrointestinal testing;
- •Specimen for testing will consist of stool specimens preserved in Cary- Blair medium following the manufacturer's instructions for use;
- •Fresh, unpreserved stool must be transferred to Cary-Blair as soon as possible after specimen collection;
- •When fresh stool is transferred into the Cary-Blair container, the maximum fill line of the container should not be exceeded;
- •There is an adequate residual volume (minimum 1.0 mL) of Cary- Blair preserved stool specimens;
- •Cary- Blair preserved stool specimens should represent a homogenous suspension (easily vortexed);
- •Cary- Blair preserved stool specimens have been stored at the following conditions prior testing:
- •Up to 4 days at Room Temperature (15 to 25˚C).
- •Up to 4 days at 2 to 8˚C (refrigerated);
- •Samples should be tested on the QIAstat-Dx® system and the reference method FilmArray within 3 hours of each other.
排除标准
- •Whole stool specimen that had been frozen;
- •Specimen that had been centrifuged;
- •Lack of clear subject identification or label on residual stool specimen;
- •Obvious physical damage of residual stool specimen;
- •Repeated specimens from the same subject;
- •Specimens in preservative collection media other than Cary-Blair;
- •Specimen containing formalin or any other fixative;
- •Rectal swab specimens
- •Specimens not collected according to manufacturer's instructions (under-filled or overfilled specimens);
- •Specimen contaminated with urine or water;
- •Leaking container.
结局指标
主要结局
Clinical sensitivity
时间窗: 8 months
Positive percent agreement PPA
Clinical specificity
时间窗: 8 months
Negative percent agreement NPA
次要结局
未报告次要终点