NCT05596032已完成不适用
Prospective Field Study to Validate the Diagnostic Performance of the IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2 on abioSCOPE®
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abionic SA
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Diagnostic performance of the IVD CAPSULE COVID-19-NP antigenic test
研究概览
简要总结
The purpose of the study is to conduct a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for antigenic determination of SARS-CoV-2 virus on the abioSCOPE® instrument.
The objective of the clinical study is to demonstrate that the IVD CAPSULE COVID-19-NP test:
- shows sensitivity:
- ≥ 80% when testing unselected symptomatic participants within the first seven days of symptom onset or asymptomatic participants when diagnosis is confirmed by RT-PCR; Or
- ≥ 90% for subjects with Ct ≤ 25.
- show ≥ 98% specificity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •provide valid informed consent before taking the tests;
- •in the case of symptomatic patients, be tested within the first seven days after the onset of symptoms.
- •Male or female, aged equal to or older than 18 years of age.
排除标准
- •Symptomatic participants who take the test after seven days after the onset of symptoms are excluded from the study
结局指标
主要结局
Diagnostic performance of the IVD CAPSULE COVID-19-NP antigenic test
时间窗: through study completion, an average of 1 month
The purpose of this work is to carry out a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for the antigenic determination of the SARS-CoV-2 virus on the abioSCOPE instrument.
次要结局
未报告次要终点
研究者
研究点 (1)
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