Sensitivity and Specificity of SARS-CoV-2 Rapid Antigen Test Compared to RT-PCR Test
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04689399|
Recruitment Status : Completed
First Posted : December 30, 2020
Last Update Posted : March 30, 2021
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4697 participants|
|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)|
|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|
- 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.
- 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 ]
- 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.
- 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.
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
|Christian von Buchwald, MD, DMSc, Professor|
|Copenhagen, Denmark, 2100|