Generic Testing of Antigen Tests for COVID-19 in Denmark

SARS-CoV2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04913116
• Other study ID #: Nat COVID Ag Project
• Status: Completed
• Start date: January 18, 2021
• Est. completion date: September 9, 2021

Study information

• Verified date: January 2022
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: September 9, 2021
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Testing
• SARS-CoV2 Infection

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Hvidovre University Hospital	Hvidovre
Denmark	Odense University Hospital	Odense

Sponsors (10)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Aalborg University Hospital, Aarhus University Hospital, Herlev and Gentofte Hospital, Odense University Hospital, Rigshospitalet, Denmark, Slagelse Hospital, Statens Serum Institut, Sydvestjysk Hospital, Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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.