Clinical Validation of the Point-of-Care MSD Influenza Test
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 391
- 试验地点
- 3
- 主要终点
- MSD Influenza A Test Results Against Cell Culture
研究概览
简要总结
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
详细描述
This is a multicenter, prospective study to evaluate the performance of the MSD Influenza Test for the detection and differentiation of influenza A (including A/H1, A/H3, and A/H5 subtypes) and influenza B. Nasal swabs from subjects presenting at the clinical care facility with ILI will be collected and tested on the MSD Influenza Test. Results from the Test will be compared to results obtained from viral culture performed on a second nasal swab at a reference laboratory.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any subject (all ages) presenting with ILI (defined as fever [subjective or documented] and cough or sore throat), and suspected of having influenza.
- •Subject (parent, guardian, or authorized legal representative) gives informed consent or assent (child) to the study, and provides signed authorization for use and disclosure of protected health information.
排除标准
- •Any subject classified as "high risk" for exposure to avian or novel influenza, as determined by a Risk-Assessment Questionnaire.
- •Subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode.
结局指标
主要结局
MSD Influenza A Test Results Against Cell Culture
时间窗: 1 day
A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared.
MSD Influenza B Test Results Against Cell Culture
时间窗: 1 day
A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.
MSD Influenza B Test Results Against Culture and PCR
时间窗: 1 day
A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.
MSD Influenza A Test Results Against Culture and PCR
时间窗: 1 day
A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.
次要结局
未报告次要终点