TY - JOUR

T1 - Accuracy and cost description of rapid antigen test compared with reverse transcriptase-polymerase chain reaction for SARS-CoV-2 detection

AU - Jakobsen, Kathrine Kronberg

AU - Jensen, Jakob Schmidt

AU - Todsen, Tobias

AU - Tolsgaard, Martin Grønnebæk

AU - Kirkby, Nikolai

AU - Lippert, Freddy

AU - Vangsted, Anne-Marie

AU - Martel, Cyril Jean-Marie

AU - Klokker, Mads

AU - von Buchwald, Christian

N1 - Articles published in the DMJ are “open access”. This means that the articles are distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits any non-commercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.

PY - 2021/6/14

Y1 - 2021/6/14

N2 - 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.

AB - 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.

KW - Antigens, Viral/analysis

KW - COVID-19/diagnosis

KW - COVID-19 Nucleic Acid Testing/economics

KW - COVID-19 Serological Testing/economics

KW - COVID-19 Testing/methods

KW - Denmark

KW - Female

KW - Humans

KW - Middle Aged

KW - Pandemics

KW - RNA, Viral/genetics

KW - RNA-Directed DNA Polymerase

KW - Reverse Transcriptase Polymerase Chain Reaction/economics

KW - SARS-CoV-2/genetics

KW - Sensitivity and Specificity

M3 - Journal article

C2 - 34169830

VL - 68

JO - Danish Medical Journal

JF - Danish Medical Journal

SN - 2245-1919

IS - 7

M1 - A03210217

ER -