跳至主要内容
临床试验/NCT04894760
NCT04894760已完成不适用

Evaluation of a Rapid Diagnostic Test of SARS-COV-2 Carried Out in the Emergency Units of Reference Hospitals in Mexico and in Primary Care: Multi-center Study

National Institute of Respiratory Diseases, Mexico1 个研究点 分布在 1 个国家目标入组 567 人开始时间: 2020年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
567
试验地点
1
主要终点
Diagnostic accuracy

研究概览

简要总结

An observational (cross-sectional) study in the emergency services of participating hospitals, receiving patients with COVID-19 and influenza, aiming to evaluate the diagnostic performance of the rapid antigen detection test for COVID-19 both in nasal sampling and saliva, in patients attending emergency services in the 2020-2021 winter season, performed on site, compared to the gold standard (RT-qPCR).

详细描述

This study aims to analyze the usefulness of rapid tests, especially: a) as a diagnostic test in people attending care for nonspecific, respiratory symptoms, in emergency services of referral hospitals b) as a diagnostic test in contacts of known patients. c) as a diagnostic test to differentiate influenza from COVID-19 in the circumstance of an overlap of both viruses in the community. d) In the 3 cases, the gold standard would be the RT-PCR test for influenza and for SARS-COV-2 performed in the usual laboratory following the officially approved technique in Mexico. If the test were in saliva, it would also be much more accepted and could come close to performing a test at home that would greatly facilitate the diagnosis. So it is important to see the performance of a saliva test.

As an observational (cross-sectional) study in the emergency services of participating hospitals, receiving patients with COVID-19 and influenza, aiming to evaluate the diagnostic performance of the rapid antigen detection test for COVID-19 both in nasal sampling and saliva, in patients attending emergency services in the 2020-2021 winter season, performed on site, compared to the gold standard (RT-qPCR).

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years of age
  • Signed Informed consent
  • Emergency room visit or screening site with respiratory symptoms consistent with COVID-19 / influenza.

排除标准

  • Positive pregnancy test
  • Lactation
  • Decision of the responsible physician to remove patient from the study.
  • Transfer of the patient to another hospital unit

结局指标

主要结局

Diagnostic accuracy

时间窗: At 24 hours

Compared with gold standard RT-PCR

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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