Accuracy and cost description of rapid antigen test compared with reverse transcriptase-polymerase chain reaction for SARS-CoV-2 detection.
Dan Med J
; 68(7)2021 06 14.
Article
in En
| MEDLINE
| ID: mdl-34169830
ABSTRACT
INTRODUCTION:
Fast and accurate detection of SARS-CoV-2 is essential in limiting the COVID-19 pandemic. Rapid antigen (AG) tests provide results within minutes; however, their accuracy has been questioned. The study aims to determine the accuracy and cost of the STANDARD Q COVID-19 AG test compared with RT-PCR.METHODS:
Individuals 18 years or older with an appointment for a RT-PCR test on 26-31 December 2020 at a public test centre in Copenhagen, Denmark were invited to participate. An oropharyngeal swab was collected for RT-PCR analysis, followed by a nasopharyngeal swab examined by the AG test (SD Biosensor). The diagnostic accuracy of the AG test was calculated with RT-PCR as reference. Costs were evaluated for both tests.RESULTS:
A total of 4,811 paired conclusive test results were collected (median age 45 years, female 53%). The RT-PCR test revealed 221 (4.6%) positive tests. The overall sensitivity and specificity of the AG test were 69.7% and 99.5%, respectively. Viral cycle threshold values were significantly higher in individuals with false negative AG tests than in individuals who were true positives. The RT-PCR test and AG test costs were 67.0 DKK (10.8 USD) and 35.0 DKK (5.7 USD), respectively, per positive case detected at 100,000 daily tests.CONCLUSIONS:
The AG test enables mass testing and provides immediate results, which is important in SARS-CoV-2 screening. The AG test is a good and relevant supplement to RT-PCR testing in public SARS-CoV-2 screenings.FUNDING:
This project received no external funding. Copenhagen Medical A/S delivering the rapid AG tests and provided test personnel but were not otherwise involved. TRIAL REGISTRATION Clinicaltrials.org NCT04716088.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Reverse Transcriptase Polymerase Chain Reaction
/
COVID-19 Testing
/
COVID-19 Nucleic Acid Testing
/
COVID-19 Serological Testing
/
SARS-CoV-2
/
COVID-19
Type of study:
Diagnostic_studies
/
Health_economic_evaluation
Limits:
Female
/
Humans
/
Middle aged
Country/Region as subject:
Europa
Language:
En
Journal:
Dan Med J
Year:
2021
Type:
Article