Covid19, Rapid Antigen Test, SARS-CoV-2
Conditions
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.
Interventions
DIAGNOSTIC_TESTStandard 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.
Sponsors
Testcenter Danmark, Statens Serum Institut
Copenhagen Emergency Medical Services
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Economic analyses | 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. |
| PCR analysis on nasopharyngeal swabs | 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. |
Countries
Denmark
Outcome results
None listed