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

NCT ID: NCT04894760

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 567 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-30
• Study Completion Date: 2021-07-31

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).

Conditions

Covid19

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Rapid Antigen Test (PanBio Ag test)

Rapid Antigen Test (PanBio Ag test)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Respiratory Diseases, Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

Rapid Test COVID

Identifier Type: -

Identifier Source: org_study_id