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OpenTrials
Completed

NCT Number: NCT04894760

Evaluation of a COVID-19 Rapid Diagnostic Test in ER Departments in Mexico: a 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Mexico City, 14080, Mexico

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid Antigen Test (PanBio Ag test)

Diagnostic Test

Rapid Antigen Test (PanBio Ag test)

Primary outcomes

  1. Diagnostic accuracy

    Time frame: At 24 hours

    Compared with gold standard RT-PCR

Sponsors and collaborators

Lead sponsor

National Institute of Respiratory Diseases, Mexico

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 20, 2021
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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