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

September 14, 2021 updated by: Christian von Buchwald
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3461

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Christian von Buchwald, MD, DMSc, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The infection pressure in the Capital Region of Denmark including Testcenter Taastrup was below 1.0%, throughout the study period

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy of anterior nasal swab in rapid antigen (Ag)-tests
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christian von Buchwald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COVID-19 rapid antigen test

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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