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pmid34169830      Dan+Med+J 2021 ; 68 (7): ä
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  • Accuracy and cost description of rapid antigen test compared with reverse transcriptase-polymerase chain reaction for SARS-CoV-2 detection #MMPMID34169830
  • Jakobsen KK; Jensen JS; Todsen T; Tolsgaard MG; Kirkby N; Lippert F; Vangsted AM; Martel CJ; Klokker M; von Buchwald C
  • Dan Med J 2021[Jun]; 68 (7): ä PMID34169830show ga
  • 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.
  • |Antigens, Viral/analysis[MESH]
  • |COVID-19 Nucleic Acid Testing/*economics[MESH]
  • |COVID-19 Serological Testing/*economics[MESH]
  • |COVID-19 Testing/*methods[MESH]
  • |COVID-19/*diagnosis/epidemiology[MESH]
  • |Denmark[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Middle Aged[MESH]
  • |Pandemics[MESH]
  • |RNA, Viral/genetics[MESH]
  • |RNA-Directed DNA Polymerase[MESH]
  • |Reverse Transcriptase Polymerase Chain Reaction/*economics[MESH]
  • |SARS-CoV-2/genetics/immunology/*isolation & purification[MESH]


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