NCT04913116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2021

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

May 12, 2021

Last Update Submit

January 24, 2022

Conditions

SARS-CoV2 InfectionCOVID-19 Testing

Keywords

antigen testRT-PCRProspective samplesRetrospective samples

Outcome Measures

Primary Outcomes (2)

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

    Performance is compared for each antigen test in relation to oropharyngeal RT-PCR samples collected simultaneously

    Up to 3 days after first initial positive COVI-19 RT-PCR test

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

    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.

    2 months

Secondary Outcomes (2)

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

    Up to 3 days after first initial positive COVI-19 RT-PCR test

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

    Up to 3 days after first initial positive COVI-19 RT-PCR test.

Study Arms (2)

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

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

Interventions

Comparison of antigen tests with RT-PCR as reference methodDIAGNOSTIC_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.

SARS-CoV-2 negativesSARS-Cov-2 positives

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

approximately 4400 adult out-patients tested for SARS-CoV-2 by RT-PCR within 24 hours prior to inclusion.

You may qualify if:

  • Age 18 years or over,
  • Capacity to give informed, written consent
  • Be able to cooperate to the additional testing.

You may not qualify if:

  • Declining additional oropharyngeal, nasal or saliva swabs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 35394449DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

SARS-CoV-2 samples are collected from SARS-CoV-2 positive and negative individuals, analyzed and discharged

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator.

Study Record Dates

First Submitted

May 12, 2021

First Posted

June 4, 2021

Study Start

January 18, 2021

Primary Completion

September 9, 2021

Study Completion

September 9, 2021

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations

DK(3)