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

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ClinicalTrials.gov Identifier: NCT04689399
Recruitment Status : Completed
First Posted : December 30, 2020
Last Update Posted : March 30, 2021
Sponsor:
Collaborators:
Testcenter Danmark, Statens Serum Institut
Copenhagen Emergency Medical Services
Information provided by (Responsible Party):
Christian von Buchwald, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Covid19 Rapid Antigen Test SARS-CoV-2 Diagnostic Test: Standard Q COVID-19 Ag - test, produced by SD Biosensor INC. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4697 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Sensitivity and Specificity of SARS-CoV-2 Rapid Antigen Test Compared to RT-PCR Test
Actual Study Start Date : December 26, 2020
Actual Primary Completion Date : March 25, 2021
Actual Study Completion Date : March 25, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy


Intervention Details:
  • Diagnostic Test: Standard Q COVID-19 Ag - test, produced by SD Biosensor INC.
    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 Measures :
  1. 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 Measures :
  1. Economic analyses [ Time Frame: It is expected that the required number of participants can be included during approximately one week after t ]
    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.

  2. PCR analysis on nasopharyngeal swabs [ Time Frame: It is expected that the required number of participants can be included during approximately one week after t ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04689399


Locations
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Denmark
Christian von Buchwald, MD, DMSc, Professor
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Testcenter Danmark, Statens Serum Institut
Copenhagen Emergency Medical Services
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Responsible Party: Christian von Buchwald, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04689399    
Other Study ID Numbers: COVID-19
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases