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

Primary Purpose

Covid19, Rapid Antigen Test, SARS-CoV-2

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Standard Q COVID-19 Ag - test, produced by SD Biosensor INC.
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Christian von Buchwald, MD, DMSc, Professor

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Economic analyses
We plan to calculate and compare costs of the antigen tests with the RT-PCR tests. Costs are calculated using the ingredients method, in which all components relevant to consider are included in cost estimates. The cost of the tests will include the test kit, instruments needed for testing and salaries of the personnel doing the swaps. Moreover, we will model the opportunity costs of the two alternatives (antigen tests vs. RT-PCR) in terms of their implications for number of sick days, in which patients/test takes cannot resume work. We anticipate that the antigen tests will be less expensive per positive test result and that they will have lower opportunity costs due to immediate test results instead of delayed test results.
PCR analysis on nasopharyngeal swabs
For a sample of the included patients the leftover material from the rapid antigen tests will subsequently be analyzed with the use of PCR to investigate if results diverge based on the anatomic location of the swabbed area. Patients included in the last two days of the study period (30th of December and 31th of December 2020) will be selected to have this additional analysis performed.

Full Information

First Posted
December 26, 2020
Last Updated
March 25, 2021
Sponsor
Rigshospitalet, Denmark
Collaborators
Testcenter Danmark, Statens Serum Institut, Copenhagen Emergency Medical Services
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1. Study Identification

Unique Protocol Identification Number
NCT04689399
Brief Title
Sensitivity and Specificity of SARS-CoV-2 Rapid Antigen Test Compared to RT-PCR Test
Official Title
Sensitivity and Specificity of SARS-CoV-2 Rapid Antigen Test Compared to RT-PCR Test
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 26, 2020 (Actual)
Primary Completion Date
March 25, 2021 (Actual)
Study Completion Date
March 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Testcenter Danmark, Statens Serum Institut, Copenhagen Emergency Medical Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The purpose of the study is to investigate the sensitivity and specificity of correct SARS-CoV-2 test results of nasopharyngeal swabs and swabs swabs from the anterior part of the nose examined by rapid antigen test (Standard Q COVID-19 Ag - test, SD Biosensor INC.) compared with swabs from the oropharynx examined by RT-PCR test among citizens who have booked an appointment for a COVID-19 test in one of Testcenter Denmark's test centers in the Capital Region.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Rapid Antigen Test, SARS-CoV-2

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4697 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Standard Q COVID-19 Ag - test, produced by SD Biosensor INC.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of the rapid antigen test of COVID-19
Time Frame
It is expected that the required number of participants can be included during approximately one week after t
Secondary Outcome Measure Information:
Title
Economic analyses
Description
We plan to calculate and compare costs of the antigen tests with the RT-PCR tests. Costs are calculated using the ingredients method, in which all components relevant to consider are included in cost estimates. The cost of the tests will include the test kit, instruments needed for testing and salaries of the personnel doing the swaps. Moreover, we will model the opportunity costs of the two alternatives (antigen tests vs. RT-PCR) in terms of their implications for number of sick days, in which patients/test takes cannot resume work. We anticipate that the antigen tests will be less expensive per positive test result and that they will have lower opportunity costs due to immediate test results instead of delayed test results.
Time Frame
It is expected that the required number of participants can be included during approximately one week after t
Title
PCR analysis on nasopharyngeal swabs
Description
For a sample of the included patients the leftover material from the rapid antigen tests will subsequently be analyzed with the use of PCR to investigate if results diverge based on the anatomic location of the swabbed area. Patients included in the last two days of the study period (30th of December and 31th of December 2020) will be selected to have this additional analysis performed.
Time Frame
It is expected that the required number of participants can be included during approximately one week after t

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 years A booked appointment for a COVID-19 test at one of Testcenter Denmark's test centers in the Capital Region Exclusion Criteria: Previously tested positive for COVID-19 Non-fluent in Danish
Facility Information:
Facility Name
Christian von Buchwald, MD, DMSc, Professor
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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