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Generic Testing of Antigen Tests for COVID-19 in Denmark

NCT04913116 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2022-01-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER

  • Herlev and Gentofte Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Slagelse Hospital

    collaborator OTHER

  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER

  • Sygehus Lillebaelt

    collaborator OTHER

  • Statens Serum Institut

    collaborator OTHER

  • Hvidovre University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2021-09-09
Completion
2021-09-09

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04913116 on ClinicalTrials.gov