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

Covid19 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894760
• Other study ID #: Rapid Test COVID
• Status: Completed
• Start date: December 30, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: January 2022
• Source: National Institute of Respiratory Diseases, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: July 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Rapid Antigen Test (PanBio Ag test)
Rapid Antigen Test (PanBio Ag test)

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"	Mexico, City

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Respiratory Diseases, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	Compared with gold standard RT-PCR	At 24 hours