NCT04689399

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,697 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19
• Rapid Antigen Test
• SARS-CoV-2

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Standard Q COVID-19 Ag - test, produced by SD Biosensor INC.	Alle Danish citizens tested for infection with SARS-CoV-2 by swabs in the oropharynx, and subsequently analysis of the specimens by RT-PCR test at Testcenter Danmark's test centers will be included in the study. Participants will, in addition to the oropharyngeal swab they are already schedule for, be examined by a rapid antigen test.

Timeline

• Start date: 2020-12-26
• Primary completion: 2021-03-25
• Completion: 2021-03-25
• First posted: 2020-12-30
• Last updated: 2021-03-30

Locations

1 site across 1 country: Denmark