Last reviewed · How we verify
NCT04913116
Generic Testing of Antigen Tests for COVID-19 in Denmark
trial testing Comparison of antigen tests with RT-PCR as reference method in SARS-CoV2 Infection in 4,000 participants. Completed in 9 September 2021.
9 September 2021
Quick facts
| Lead sponsor | Hvidovre University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 4,000 |
| Start date | 18 January 2021 |
| Primary completion | 9 September 2021 |
| Estimated completion | 9 September 2021 |
| Sites | 3 locations across Denmark |
Drugs / interventions tested
- Comparison of antigen tests with RT-PCR as reference method
Conditions studied
- SARS-CoV2 Infection — all drugs for SARS-CoV2 Infection →
- COVID-19 Testing — all drugs for COVID-19 Testing →
Sponsor
Hvidovre University Hospital
Who can join
18 and older, any sex, with SARS-CoV2 Infection or COVID-19 Testing. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Schneider UV, Knudsen JD, Koch A, Kirkby NS, et al · · 2022 · cited 2× · PMID 35394449 · DOI 10.2196/35706
Verify or expand the search:
- PubMed search for NCT04913116
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for SARS-CoV2 Infection
Currently open trials in the same condition.
- NCT05852873 — PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway · Phase 3 · active not recruiting
- NCT04910269 — Outpatient Treatment With Anti-Coronavirus Immunoglobulin · Phase 3 · recruiting
- NCT04830852 — Pediatric COVID Outcomes Study (PECOS) · active not recruiting
- NCT04844242 — MISC COVID-19 Study in Pediatric Population · recruiting
Other Hvidovre University Hospital trials
Trials by the same sponsor.
- NCT07561164 — Feasibility of a Co-designed Mobility Intervention After Hip Fracture Surgery · NA · not yet recruiting
- NCT06909240 — Progressive Gait Training After First-time Deep Venous Thrombosis: Clinical Effectiveness and Involved Mecanisms (The DV · NA · recruiting
- NCT07054216 — Probiotic for Infants · NA · recruiting
- NCT07029334 — Effectiveness Evaluation of Social Prescribing · recruiting
- NCT06789484 — Characterization of the Gastrointestinal Microbiota in Newborn Infants · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04913116 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hvidovre University Hospital
- Last refreshed: 26 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04913116.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing