Sensitivity and Specificity of SARS-CoV-2 Rapid Antigen Test Compared to RT-PCR Test

NCT04689399 | Completed

• 1 other identifier: COVID-19
• Study Type: interventional
• Target: 4,697
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to investigate the sensitivity and specificity of the rapid antigen test compared to RT-PCR test performed on samples from the nasopharynx and the anterior nasal cavity and the oropharynx, respectively.

Conditions

Covid19; Rapid Antigen Test; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the rapid antigen test of COVID-19

  It is expected that the required number of participants can be included during approximately one week after t

Secondary Outcomes (2)

• Economic analyses

  It is expected that the required number of participants can be included during approximately one week after t

• PCR analysis on nasopharyngeal swabs

  It is expected that the required number of participants can be included during approximately one week after t

Interventions

Standard Q COVID-19 Ag - test, produced by SD Biosensor INC. DIAGNOSTIC_TEST

Alle Danish citizens tested for infection with SARS-CoV-2 by swabs in the oropharynx, and subsequently analysis of the specimens by RT-PCR test at Testcenter Danmark's test centers will be included in the study. Participants will, in addition to the oropharyngeal swab they are already schedule for, be examined by a rapid antigen test.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• A booked appointment for a COVID-19 test at one of Testcenter Denmark's test centers in the Capital Region

You may not qualify if:

• Previously tested positive for COVID-19
• Non-fluent in Danish

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Testcenter Danmark, Statens Serum Institut: collaborator
• Copenhagen Emergency Medical Services: collaborator

Study Sites (1)

Christian von Buchwald, MD, DMSc, Professor

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Citizens who have booked an appointment and shows up for a COVID-19 test at a Testcenter Denmark test center in the Capital Region are offered to participate in the project.

Study Record Dates

• First Submitted: December 26, 2020
• First Posted: December 30, 2020
• Study Start: December 26, 2020
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)