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

Rigshospitalet

Status: Completed

Conditions: Covid19; SARS-CoV-2; Rapid Antigen Test

Treatments: Diagnostic Test: Standard Q COVID-19 Ag - test, produced by SD Biosensor INC.

Study type: Interventional

Funder types: Other

Identifiers

NCT04689399

COVID-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,697 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)