NCT04913116

Generic Testing of Antigen Tests for COVID-19 in Denmark

Agreement of Antigen Tests on Oral Pharyngeal Swabs or Less Invasive Testing With PCR, for Detecting SARS-CoV-2 in Adults: A Prospective Nationwide Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (actual)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate the analytical and clinical sensitivity and specificity of antigen tests performed as oropharyngeal swabs, outer nasal swabs, saliva swabs or breath tests including self-tests for SARS-CoV-2 towards standard RT-PCR testing. For each test 200 SARS-CoV-2 positive and 200 SARS-CoV-2 negative individuals previously defined by RT-PCR are tested. When tested an additional RT-PCR test is performed to verify status. Analytical sensitivity and specificity is determined on 210 SARS-CoV-2 positive samples with known Cq and 100 SARS-CoV-2 negative samples. 30 companies with a total of 55 tests participate in this nationwide study.

Conditions

• SARS-CoV2 Infection
• COVID-19 Testing

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Comparison of antigen tests with RT-PCR as reference method	Antigen tests are performed locally including sampling from multiple anatomical testing sites. A reference oropharyngeal swab is always send for RT-PCR for SARS-CoV-2 at DTU to verify the status of the patient. RT-PCR samples from other anatomical test locations may be included.

Timeline

• Start date: 2021-01-18
• Primary completion: 2021-09-09
• Completion: 2021-09-09
• First posted: 2021-06-04
• Last updated: 2022-01-26

Locations

3 sites across 1 country: Denmark