NCT04678024Unknown不适用
Multicentric Sensitivity Assessment of Antibody Diagnostic Tests Developed for Diagnosis of SARS-CoV2 Infection
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2020年11月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
The primary objective of this study is to test the diagnostic sensitivity of antibody tests for the diagnosis of SARS-CoV2 infection, available to clinical laboratories, within a national network of hospitals carrying out research activities. Test the diagnostic specificity of antibody tests for the diagnosis of SARS-CoV2 infection. Complete a systematic evaluation of the different approaches. Perform Health technology Assessment (HITA) of the methodologies under study, in order to verify their reliability to the immunoglobulin levels produced by each individual exposed patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients or individuals exposed to Sars-Cov2 Infection.
排除标准
- •There are no criteria for excluding patients or individuals, if not the refusal to participate to project
结局指标
主要结局
Sensitivity
时间窗: Up to 22 weeks
Sensitivity and Specificity Evaluation in Diagnostic Sierological tests
次要结局
- Specificity(Through study completion, an average of 1 year)
研究者
研究点 (1)
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