Q-POC SARS-CoV-2 Assay (Q27001) Clinical Performance Study Plan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 877
- 试验地点
- 6
- 主要终点
- Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test
研究概览
简要总结
Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation
详细描述
The Q-POC SARS-CoV-2 Assay is a real-time PCR test intended for use on the Q-POC instrument for the qualitative detection of nucleic acids from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in nasal mid-turbinate swabs (MTSW) obtained from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity or moderate complexity tests.
The Q-POC SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use of the Q-POC SARS-CoV-2 Assay in conjunction with the Q-POC instrument (Q29001).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be over the age of 18 years.
- •Participants must present with symptoms indicative of SARS-CoV-2 infection, within 0-5 days of symptom onset.
- •Participants must have capacity to give informed consent.
排除标准
- •Participant is under the age of 18 years.
- •Participant does not have symptoms of SARS-CoV-2 infection.
- •Participant lacks capacity to give informed consent.
结局指标
主要结局
Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test
时间窗: One hour
The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to 95% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results
Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test
时间窗: One hour
The acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to 98% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results.
次要结局
未报告次要终点