Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test on Nasopharyngeal Specimens i
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Evaluation of COVID VIRO® diagnostic sensitivity
研究概览
简要总结
The current prospective study was designed to assess the diagnostic specificity and sensitivity of a novel antigen-based rapid detection test (COVID-VIRO®) on nasopharyngeal specimens in comparison to the reference test in a real-life setting
详细描述
Two nasopharyngeal swab specimens will be concurrently collected on:
- adult patients hospitalized in the Infectious Diseases Department of the Centre Hospitalier Régional d'Orléans (CHRO) for confirmed SARS-CoV-2 infection,
- or symptomatic or asymptomatic subjects voluntarily accessing the COVID-19 Screening Department of the CHRO to perform a diagnostic test. COVID VIRO® diagnostic.
Specificity and sensitivity are assessed in comparison to real-time RT-qPCR results.
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
- •Adult patients (>18 years old) already having a SARS-CoV-2 RT-qPCR positive result within 5 days
- •Adult patients (>18 years old) requiring a SARS-CoV-2 RT-qPCR on nasopharyngeal swab specimen for any reason
排除标准
- •Patients non wishing to participate
- •Under guardianship or curatorship or safeguard of justice patients
- •Inability to join the hospital other than by public transport
结局指标
主要结局
Evaluation of COVID VIRO® diagnostic sensitivity
时间窗: Month 1
COVID-VIRO® sensitivity is calculated using the RT-qPCR results as reference test, according to the following formulas: Sensitivity (%) = 100 x \[Positive/ (Positive + Negative)\]
Evaluation of COVID VIRO® diagnostic specificity
时间窗: Month 1
COVID-VIRO® specificity is calculated using the RT-qPCR results as reference test, according to the following formulas: Specificity (%) = 100 x \[Negative / (Negative + Positive)\]
次要结局
- Evaluation of COVID VIRO® diagnostic sensitivity for RT-qPCR Cycle threshold value < or > 28(Month 1)