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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 : June 4, 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

Tracking Information
First Submitted Date May 12, 2021
First Posted Date June 4, 2021
Last Update Posted Date June 4, 2021
Actual Study Start Date January 30, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2021)
  • 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
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 30, 2021)
  • 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).
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Generic Testing of Antigen Tests for COVID-19 in Denmark
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
SARS-CoV-2 samples are collected from SARS-CoV-2 positive and negative individuals, analyzed and discharged
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.
Condition
  • SARS-CoV2 Infection
  • COVID-19 Testing
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.
Study Groups/Cohorts
  • 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
    Intervention: Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method
  • 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
    Intervention: Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 30, 2021)
4400
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Uffe Schneider, PHD +4538623189 uffe.vest.schneider@regionh.dk
Contact: Gorm Lisby, PHD +4538622416 jan.gorm.lisby@regionh.dk
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT04913116
Other Study ID Numbers Nat COVID Ag Project
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Uffe Schneider, Hvidovre University Hospital
Study Sponsor Hvidovre University Hospital
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
Investigators Not Provided
PRS Account Hvidovre University Hospital
Verification Date May 2021