Generic Testing of Antigen Tests for COVID-19 in Denmark

Completed

• Conditions: SARS-CoV2 Infection; COVID-19 Testing
• Interventions: Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method

• Registration Number: NCT04913116
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-18
• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-30
• Study First Posted: 2021-06-04
• Primary Completion: 2021-09-09
• Study Completion: 2021-09-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Age 18 years or over,
• Capacity to give informed, written consent
• Be able to cooperate to the additional testing.

Exclusion Criteria

• Individuals not fulfilling the inclusion criteria
• Declining additional oropharyngeal, nasal or saliva swabs.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SARS-Cov-2 positives	Comparison of antigen tests with RT-PCR as reference method	200 individuals will be tested by each antigen test. Testing is done with up to three swabs at a time from each anatomical test location
SARS-CoV-2 negatives	Comparison of antigen tests with RT-PCR as reference method	200 individuals will be tested by each antigen test. Testing is done with up to three swabs at a time from each anatomical test location

Primary Outcome Measures

Name	Time	Method
Clinical sensitivity and specificity of each antigen test compared to RT-PCR test result.	Up to 3 days after first initial positive COVI-19 RT-PCR test	Performance is compared for each antigen test in relation to oropharyngeal RT-PCR samples collected simultaneously
Analytical sensitivity and specificity of each antigen test on retrospectively collected SARS-CoV-2 positive and negative samples.	2 months	SARS-CoV-2 positive samples are stratified into subgroups according to Cq by RT-PCR and frozen samples in universal transport medium is tested on each antigen test.

Secondary Outcome Measures

Name	Time	Method
Clinical sensitivity compared to RT-PCR result with the later stratified into low, intermediate and high Cq	Up to 3 days after first initial positive COVI-19 RT-PCR test	Performance of each antigen test in relation to the cycle of quantification Cq by RT-PCR stratified into low (Cq \<25), intermediate (Cq 25-35) and High (Cq \>35).
Agreement between oropharyngeal swabs and tests from other anatomical test locations by RT-PCR.	Up to 3 days after first initial positive COVI-19 RT-PCR test.	Antigen an RT-PCR tests are performed from multiple anatomical sampling sites on each teste individual.

Trial Locations

Locations (3)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark