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临床试验/NCT04467008
NCT04467008已完成不适用

Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop

CMC Ambroise Paré1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
113
试验地点
1
主要终点
Positivity of the rapid diagnostic test

研究概览

简要总结

This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection.

详细描述

The Covid-19 pandemic requires a reliable diagnosis of affected patients in order to manage them in an appropriate manner, in the appropriate departments. Furthermore, the diagnostic reference at the time of this study is based on reverse transcription by reaction in polymerase chain reaction (RT-PCR) on a nasopharyngeal swab taken. This method has may yield false negatives (up to 30% depending on the series) and its lead time is several hours.

Alternatives are therefore being developed, in particular rapid blood tests. The rapid diagnostic test distributed by Biosynex has been evaluated by the National Reference Center for Respiratory Infections Viruses as very specific for the detection of IgG + IgM (93%).

As part of the evaluation of this test, it was used in patients with severe Covid-19 disease, requiring hospitalization in critical care in order to be able to establish their reliability in a clinical context where many confounding factors may occur, such as lymphopenia or systemic inflammation. However, the early diagnosis of this patient population remains critical in order to be able to refer them to the appropriate services.

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

入选标准

  • Confirmed COVID-19 diagnosis with at least one positive RT-PCR

排除标准

  • 未提供

结局指标

主要结局

Positivity of the rapid diagnostic test

时间窗: Immediate, up to 1 day.

Positivity of the rapid diagnostic test, assessed by the presence of either IgM or IgG

次要结局

未报告次要终点

研究者

发起方
CMC Ambroise Paré
申办方类型
Other
责任方
Sponsor

研究点 (1)

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