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Diagnostic Accuracy of Rapid Antigen Test Based on Anterior Nasal Swab Compared With RT-PCR for SARS-CoV-2 Detection.

Sponsor
Christian von Buchwald (Other)
Overall Status
Completed
CT.gov ID
NCT05045846
Collaborator
(none)
3,461
Enrollment
1
Location
29
Actual Duration (Days)
3632.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to determine the accuracy of anterior nasal swab in rapid antigen (Ag)-tests in a low SARS-CoV-2 prevalence and massive screened community.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3461 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    Diagnostic Accuracy of Rapid Antigen Test Based on Anterior Nasal Swab Compared With RT-PCR for SARS-CoV-2 Detection.
    Actual Study Start Date :
    Mar 1, 2021
    Actual Primary Completion Date :
    Mar 30, 2021
    Actual Study Completion Date :
    Mar 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy of anterior nasal swab in rapid antigen (Ag)-tests [1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Citizens, above 18 years of age, who had self-booked an appointment for COVID-19 test at Testcenter Taastrup, Copenhagen, Denmark, in the period of 2nd of March to 22nd of March were offered to participate in the project
    Exclusion Criteria:
    • Patients referred to COVID-19 testing by a doctor with symptoms of COVID-19 were tested in a separate section of the test centers and are not included in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Christian von Buchwald, MD, DMSc, Professor Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Christian von Buchwald

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christian von Buchwald, Medical Doctor, investigator, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT05045846
    Other Study ID Numbers:
    • COVID-19 rapid antigen test
    First Posted:
    Sep 16, 2021
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Christian von Buchwald, Medical Doctor, investigator, Rigshospitalet, Denmark
    rapid antigen test

    Study Results

    No Results Posted as of Sep 16, 2021