Generic Testing of Antigen Tests for COVID-19 in Denmark

Hvidovre University Hospital

Status: Completed

Conditions: SARS-CoV2 Infection; COVID-19 Testing

Treatments: Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method

Study type: Observational

Funder types: Other

Identifiers

NCT04913116

Nat COVID Ag Project

Details and patient eligibility

About

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.

Enrollment: 4,000 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

4,000 participants in 2 patient groups

SARS-Cov-2 positives

Description:

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

Treatment:

Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method

SARS-CoV-2 negatives

Description:

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

Treatment:

Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method