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Clinical Trials/NCT04689399
NCT04689399
Completed
Not Applicable

Sensitivity and Specificity of SARS-CoV-2 Rapid Antigen Test Compared to RT-PCR Test

Rigshospitalet, Denmark1 site in 1 country4,697 target enrollmentDecember 26, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Rigshospitalet, Denmark
Enrollment
4697
Locations
1
Primary Endpoint
Sensitivity and specificity of the rapid antigen test of COVID-19
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This project aims to investigate the sensitivity and specificity of the rapid antigen test compared to RT-PCR test performed on samples from the nasopharynx and the anterior nasal cavity and the oropharynx, respectively.

Detailed Description

The purpose of the study is to investigate the sensitivity and specificity of correct SARS-CoV-2 test results of nasopharyngeal swabs and swabs swabs from the anterior part of the nose examined by rapid antigen test (Standard Q COVID-19 Ag - test, SD Biosensor INC.) compared with swabs from the oropharynx examined by RT-PCR test among citizens who have booked an appointment for a COVID-19 test in one of Testcenter Denmark's test centers in the Capital Region.

Registry
clinicaltrials.gov
Start Date
December 26, 2020
End Date
March 25, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christian von Buchwald

Professor

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years
  • A booked appointment for a COVID-19 test at one of Testcenter Denmark's test centers in the Capital Region

Exclusion Criteria

  • Previously tested positive for COVID-19
  • Non-fluent in Danish

Outcomes

Primary Outcomes

Sensitivity and specificity of the rapid antigen test of COVID-19

Time Frame: It is expected that the required number of participants can be included during approximately one week after t

Secondary Outcomes

  • Economic analyses(It is expected that the required number of participants can be included during approximately one week after t)
  • PCR analysis on nasopharyngeal swabs(It is expected that the required number of participants can be included during approximately one week after t)

Study Sites (1)

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