Skip to main content
OpenTrials
Completed

NCT Number: NCT04913116

Generic Testing of Antigen Tests for COVID-19 in Denmark

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

SARS-CoV2 Infection COVID-19 COVID-19 Testing Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comparison of antigen tests with RT-PCR as reference method

Diagnostic Test

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.

Primary outcomes

  1. Clinical sensitivity and specificity of each antigen test compared to RT-PCR test result.

    Time frame: 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

  2. Analytical sensitivity and specificity of each antigen test on retrospectively collected SARS-CoV-2 positive and negative samples.

    Time frame: 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 outcomes

  1. Clinical sensitivity compared to RT-PCR result with the later stratified into low, intermediate and high Cq

    Time frame: 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).

  2. Agreement between oropharyngeal swabs and tests from other anatomical test locations by RT-PCR.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Herlev and Gentofte Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark
  • Slagelse Hospital
  • Statens Serum Institut
  • Sygehus Lillebaelt

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2021
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.