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Diagnostic Accuracy of Self-sampling Versus Healthcare Sampling for Coronavirus-Disease-2019 Detection.

NCT05209178 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3070

Last updated 2022-05-11

No results posted yet for this study

Summary

The current Coronavirus Disease 2019 (COVID-19) pandemic continues to be a worldwide health emergency. To contain the spread of disease, high demands on testing availability and capacity are observed. Although polymerase chain reaction (PRC) is the golden standard method in detecting infection with COVID-19, the procedure is time consuming and requires healthcare personnel and laboratories. Rapid antigen tests, however, have several potential benefits including greater scalability and results are provided much quicker. So far, sampling for rapid antigen tests is predominantly performed by health care personnel. Though, the testing and analyzing procedure of an antigen test seems manageable by laymen but the validity of a self-performed rapid antigen test is sparsely examined. Thus, the investigators wish to conduct a study evaluating the diagnostic accuracy of self-performed rapid antigen test for detecting COVID-19 infection by comparing self-performed and healthcare-performed rapid antigen tests on the same individual while using a PCR tests as a control.

Conditions

  • COVID-19 Pandemic

Interventions

DIAGNOSTIC_TEST

Collection of nasal and oropharyngeal specimen for COVID19 antigen test

Regarding two independent sampling procedures from the anterior part of the nose and the oropharynx, participants are randomized to either perform the sampling by themselves with written instructions or having the procedure performed by trained personnel. The specimen is meant for a rapid antigen test for COVID-19 infection.

Sponsors & Collaborators

  • Emergency Medical Services, Capital Region, Denmark

    collaborator OTHER_GOV

  • Technical University of Denmark

    collaborator OTHER

  • Copenhagen Medical A/S

    collaborator UNKNOWN

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Kathrine K Jakobsen, MD · Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-04
Primary Completion
2022-03-25
Completion
2022-05-06

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05209178 on ClinicalTrials.gov