학술논문
Diagnostic accuracy of SARS-CoV-2 rapid antigen self-tests in asymptomatic individuals in the omicron period: a cross-sectional study.
Document Type
Academic Journal
Author
Venekamp RP; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.; Schuit E; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.; Hooft L; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.; Veldhuijzen IK; Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.; van den Bijllaardt W; Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, the Netherlands; Department of Infection Control, Amphia Hospital, Breda, the Netherlands.; Pas SD; Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, the Netherlands; Microvida Laboratory for Medical Microbiology, Bravis Hospital, Roosendaal, the Netherlands.; Zwart VF; Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, the Netherlands.; Lodder EB; Public Health Service West-Brabant, Breda, the Netherlands.; Hellwich M; Public Health Service Hart voor Brabant, Tilburg, the Netherlands.; Koppelman M; National Screening Laboratory of Sanquin, Sanquin Blood Supply Foundation, Amsterdam, the Netherlands.; Molenkamp R; Department of Viroscience, Erasmus MC, Rotterdam, the Netherlands.; Wijers CJH; Public Health Service Rotterdam-Rijnmond, Rotterdam, the Netherlands.; Vroom IH; Public Health Service Rotterdam-Rijnmond, Rotterdam, the Netherlands.; Smeets LC; Reinier Haga Medical Diagnostic Center, Delft, the Netherlands.; Nagel-Imming CRS; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.; Han WGH; Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.; van den Hof S; Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.; Kluytmans JAJW; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.; van de Wijgert JHHM; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.; Moons KGM; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address: k.g.m.moons@umcutrecht.nl.
Source
Publisher: Elsevier Country of Publication: England NLM ID: 9516420 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1469-0691 (Electronic) Linking ISSN: 1198743X NLM ISO Abbreviation: Clin Microbiol Infect Subsets: MEDLINE
Subject
Language
English
Abstract
Objectives: To assess the performances of three commonly used antigen rapid diagnostic tests used as self-tests in asymptomatic individuals in the Omicron period.
Methods: We performed a cross-sectional diagnostic test accuracy study in the Omicron period in three public health service COVID-19 test sites in the Netherlands, including 3600 asymptomatic individuals aged ≥ 16 years presenting for SARS-CoV-2 testing for any reason except confirmatory testing after a positive self-test. Participants were sampled for RT-PCR (reference test) and received one self-test (either Acon Flowflex [Flowflex], MP Biomedicals (MPBio), or Siemens-Healthineers CLINITEST [CLINITEST]) to perform unsupervised at home. Diagnostic accuracies of each self-test were calculated.
Results: Overall sensitivities were 27.5% (95% CI, 21.3-34.3%) for Flowflex, 20.9% (13.9-29.4%) for MPBio, and 25.6% (19.1-33.1%) for CLINITEST. After applying a viral load cut-off (≥5.2 log10 SARS-CoV-2 E-gene copies/mL), sensitivities increased to 48.3% (37.6-59.2%), 37.8% (22.5-55.2%), and 40.0% (29.5-51.2%), respectively. Specificities were >99% for all tests in most analyses.
Discussion: The sensitivities of three commonly used SARS-CoV-2 antigen rapid diagnostic tests when used as self-tests in asymptomatic individuals in the Omicron period were very low. Antigen rapid diagnostic test self-testing in asymptomatic individuals may only detect a minority of infections at that point in time. Repeated self-testing in case of a negative self-test is advocated to improve the diagnostic yield, and individuals should be advised to re-test when symptoms develop.
(Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Methods: We performed a cross-sectional diagnostic test accuracy study in the Omicron period in three public health service COVID-19 test sites in the Netherlands, including 3600 asymptomatic individuals aged ≥ 16 years presenting for SARS-CoV-2 testing for any reason except confirmatory testing after a positive self-test. Participants were sampled for RT-PCR (reference test) and received one self-test (either Acon Flowflex [Flowflex], MP Biomedicals (MPBio), or Siemens-Healthineers CLINITEST [CLINITEST]) to perform unsupervised at home. Diagnostic accuracies of each self-test were calculated.
Results: Overall sensitivities were 27.5% (95% CI, 21.3-34.3%) for Flowflex, 20.9% (13.9-29.4%) for MPBio, and 25.6% (19.1-33.1%) for CLINITEST. After applying a viral load cut-off (≥5.2 log10 SARS-CoV-2 E-gene copies/mL), sensitivities increased to 48.3% (37.6-59.2%), 37.8% (22.5-55.2%), and 40.0% (29.5-51.2%), respectively. Specificities were >99% for all tests in most analyses.
Discussion: The sensitivities of three commonly used SARS-CoV-2 antigen rapid diagnostic tests when used as self-tests in asymptomatic individuals in the Omicron period were very low. Antigen rapid diagnostic test self-testing in asymptomatic individuals may only detect a minority of infections at that point in time. Repeated self-testing in case of a negative self-test is advocated to improve the diagnostic yield, and individuals should be advised to re-test when symptoms develop.
(Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)