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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689399
• Other study ID #: COVID-19
• Status: Completed
• Phase: N/A
• Start date: December 26, 2020
• Est. completion date: March 25, 2021

Study information

• Verified date: March 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4697
• Est. completion date: March 25, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Hypersensitivity
• Rapid Antigen Test
• SARS-CoV-2

Intervention

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.

Locations

Country	Name	City	State
Denmark	Christian von Buchwald, MD, DMSc, Professor	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen Emergency Medical Services, Testcenter Danmark, Statens Serum Institut

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	It is expected that the required number of participants can be included during approximately one week after t
Secondary	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.	It is expected that the required number of participants can be included during approximately one week after t