Generic Testing of Antigen Tests for COVID-19 in Denmark

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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SARS-CoV2 Infection, COVID-19 Testing

Intervention / Treatment
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* Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-Cov-2 positives<br>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 | Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method<br>* 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.<br>|
| SARS-CoV-2 negatives<br>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 | Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical sensitivity and specificity of each antigen test compared to RT-PCR test result. | Performance is compared for each antigen test in relation to oropharyngeal RT-PCR samples collected simultaneously | Up to 3 days after first initial positive COVI-19 RT-PCR test | 
| Analytical sensitivity and specificity of each antigen test on retrospectively collected SARS-CoV-2 positive and negative samples. | 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical sensitivity compared to RT-PCR result with the later stratified into low, intermediate and high Cq | 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). | Up to 3 days after first initial positive COVI-19 RT-PCR test | 
| Agreement between oropharyngeal swabs and tests from other anatomical test locations by RT-PCR. | Antigen an RT-PCR tests are performed from multiple anatomical sampling sites on each teste individual. | Up to 3 days after first initial positive COVI-19 RT-PCR test. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antigen test, RT-PCR, Prospective samples, Retrospective samples