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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: Rapid Antigen Test (PanBio Ag test)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Rapid Antigen Test (PanBio Ag test)|Rapid Antigen Test (PanBio Ag test)|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rapid test, diagnosis, antigen test