Clinical trial NCT04913116: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection
COVID-19 Testing
Keywords: antigen test
RT-PCR
Prospective samples
Retrospective samples
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: Herlev and Gentofte Hospital
name: Odense University Hospital
name: Aarhus University Hospital
name: Rigshospitalet, Denmark
name: Slagelse Hospital
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Sygehus Lillebaelt
name: Statens Serum Institut
First posted: 2021-06-04
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Clinical sensitivity and specificity of each antigen test compared to RT-PCR test result.
timeFrame: Up to 3 days after first initial positive COVI-19 RT-PCR test
measure: Analytical sensitivity and specificity of each antigen test on retrospectively collected SARS-CoV-2 positive and negative samples.
timeFrame: 2 months
Secondary outcomes:
measure: Clinical sensitivity compared to RT-PCR result with the later stratified into low, intermediate and high Cq
timeFrame: Up to 3 days after first initial positive COVI-19 RT-PCR test
measure: Agreement between oropharyngeal swabs and tests from other anatomical test locations by RT-PCR.
timeFrame: Up to 3 days after first initial positive COVI-19 RT-PCR test.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
citation: Schneider UV, Knudsen JD, Koch A, Kirkby NS, Lisby JG. An Agreement of Antigen Tests on Oral Pharyngeal Swabs or Less Invasive Testing With Reverse Transcription Polymerase Chain Reaction for Detecting SARS-CoV-2 in Adults: Protocol for a Prospective Nationwide Observational Study. JMIR Res Protoc. 2022 May 4;11(5):e35706. doi: 10.2196/35706.