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

January 17, 2022 updated by: National Institute of Respiratory Diseases, Mexico

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

567

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico, City, Mexico, 14080
        • Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients that arrive to the ER department of each reference center.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: At 24 hours
Compared with gold standard RT-PCR
At 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Respiratory Diseases, Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rapid Test COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

No plan yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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