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Generic Testing of Antigen Tests for COVID-19 in Denmark

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ClinicalTrials.gov Identifier: NCT04913116
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : August 25, 2021
Sponsor:
Collaborators:
Aalborg University Hospital
Herlev and Gentofte Hospital
Odense University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Slagelse Hospital
Sydvestjysk Hospital
Sygehus Lillebaelt
Statens Serum Institut
Information provided by (Responsible Party):
Uffe Schneider, Hvidovre University Hospital

Brief 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.


Condition or disease Intervention/treatment
SARS-CoV2 Infection COVID-19 Testing Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method

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Study Type : Observational
Estimated Enrollment : 4400 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : January 30, 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : October 1, 2021

Group/Cohort Intervention/treatment
SARS-Cov-2 positives
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
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.

SARS-CoV-2 negatives
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
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 Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
SARS-CoV-2 samples are collected from SARS-CoV-2 positive and negative individuals, analyzed and discharged


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
approximately 4400 adult out-patients tested for SARS-CoV-2 by RT-PCR within 24 hours prior to inclusion.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04913116


Contacts
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Contact: Uffe Schneider, PHD +4538623189 uffe.vest.schneider@regionh.dk
Contact: Gorm Lisby, PHD +4538622416 jan.gorm.lisby@regionh.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Kasper Mortensen, MD    +4540256392    kaspmort@rm.dk   
Contact: Svend Ellermann-Eriksen, MD, PHD, DMSc    +4578455600    sveell@rm.dk   
Hvidovre University Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Uffe Schneider, MD, PhD    +4538623189    uffe.vest.schneider@regionh.dk   
Contact: Gorm Lisby, MD, PhD    +4538622416    jan.gorm.lisby@regionh.dk   
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Charlotte Agergaard, MD    +4521733440    charlotte.agergaard@rsyd.dk   
Sponsors and Collaborators
Hvidovre University Hospital
Aalborg University Hospital
Herlev and Gentofte Hospital
Odense University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Slagelse Hospital
Sydvestjysk Hospital
Sygehus Lillebaelt
Statens Serum Institut
  Study Documents (Full-Text)

Documents provided by Uffe Schneider, Hvidovre University Hospital:
Study Protocol  [PDF] May 19, 2021

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Responsible Party: Uffe Schneider, Principal Investigator., Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04913116    
Other Study ID Numbers: Nat COVID Ag Project
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uffe Schneider, Hvidovre University Hospital:
antigen test
RT-PCR
Prospective samples
Retrospective samples