Evaluation of a COVID-19 Rapid Diagnostic Test in ER Departments in Mexico: a Multi-center Study

Completed

• Conditions: Covid19

• Registration Number: NCT04894760
• Lead Sponsor: National Institute of Respiratory Diseases, Mexico

Brief Summary

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).

Detailed Description

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).

Study Timeline

• Study Start: 2020-12-30
• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-20
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 567

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	At 24 hours	Compared with gold standard RT-PCR

Trial Locations

Locations (1)

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"; 🇲🇽 Mexico, City, Mexico