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

Not Applicable

Completed

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

• Registration Number: NCT04689399
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2020-12-26
• Study First Submitted: 2020-12-26
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-30
• Status Verified: 2021-03
• Primary Completion: 2021-03-25
• Study Completion: 2021-03-25
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4697

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the rapid antigen test of COVID-19	It is expected that the required number of participants can be included during approximately one week after t

Secondary Outcome Measures

Name	Time	Method
Economic analyses	It is expected that the required number of participants can be included during approximately one week after t	We plan to calculate and compare costs of the antigen tests with the RT-PCR tests. Costs are calculated using the ingredients method, in which all components relevant to consider are included in cost estimates. The cost of the tests will include the test kit, instruments needed for testing and salaries of the personnel doing the swaps. Moreover, we will model the opportunity costs of the two alternatives (antigen tests vs. RT-PCR) in terms of their implications for number of sick days, in which patients/test takes cannot resume work. We anticipate that the antigen tests will be less expensive per positive test result and that they will have lower opportunity costs due to immediate test results instead of delayed test results.
PCR analysis on nasopharyngeal swabs	It is expected that the required number of participants can be included during approximately one week after t	For a sample of the included patients the leftover material from the rapid antigen tests will subsequently be analyzed with the use of PCR to investigate if results diverge based on the anatomic location of the swabbed area. Patients included in the last two days of the study period (30th of December and 31th of December 2020) will be selected to have this additional analysis performed.

Trial Locations

Locations (1)

Christian von Buchwald, MD, DMSc, Professor; 🇩🇰 Copenhagen, Denmark