NCT04894760

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
567

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

April 12, 2021

Last Update Submit

January 17, 2022

Conditions

Covid19

Keywords

rapid testdiagnosisantigen test

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Compared with gold standard RT-PCR

    At 24 hours

Interventions

Rapid Antigen Test (PanBio Ag test)DIAGNOSTIC_TEST

Rapid Antigen Test (PanBio Ag test)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • At least 18 years of age
  • Signed Informed consent
  • Emergency room visit or screening site with respiratory symptoms consistent with COVID-19 / influenza.

You may not qualify if:

  • Positive pregnancy test
  • Lactation
  • Decision of the responsible physician to remove patient from the study.
  • Transfer of the patient to another hospital unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Mexico City, 14080, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal swab sampling and Saliva testing

MeSH Terms

Conditions

COVID-19Disease

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

May 20, 2021

Study Start

December 30, 2020

Primary Completion

June 30, 2021

Study Completion

July 31, 2021

Last Updated

January 19, 2022

Record last verified: 2022-01

Locations

ME(1)