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Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid and antibody tests up to 22 August 2020

2021-11Artigo científico Acesso aberto
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dc.contributor.authorWalle, I.V.
dc.contributor.authorLeitmeyer, K.
dc.contributor.authorBroberg, E.K.
dc.contributor.authorThe European Covid-19 microbiological laboratories group
dc.date.accessioned2022-07-12T11:11:19Z
dc.date.available2022-07-12T11:11:19Z
dc.date.issued2021-11
dc.descriptionEuropean COVID-19 microbiological laboratories group: Portugal - Instituto Nacional de Saúde Dr. Ricardo Jorge (Raquel Guiomar, Líbia Zé-Zé, Inês Costa).pt_PT
dc.description.abstractBackground: Reliable testing for SARS-CoV-2 is key for the management of the COVID-19 pandemic. Aim: We estimate diagnostic accuracy for nucleic acid and antibody tests 5 months into the COVID-19 pandemic, and compare with manufacturer-reported accuracy. Methods: We reviewed the clinical performance of SARS-CoV-2 nucleic acid and antibody tests based on 93,757 test results from 151 published studies and 20,205 new test results from 12 countries in the European Union and European Economic Area (EU/ EEA). Results: Pooling the results and considering only results with 95% confidence interval width≤5%, we found four nucleic acid tests, including one pointof-care test and three antibody tests, with a clinical sensitivity ≥95% for at least one target population (hospitalised, mild or asymptomatic, or unknown). Nine nucleic acid tests and 25 antibody tests, 12 of them point-of-care tests, had a clinical specificity of ≥98%. Three antibody tests achieved both thresholds. Evidence for nucleic acid point-of-care tests remains scarce at present, and sensitivity varied substantially. Study heterogeneity was low for eight of 14 sensitivity and 68 of 84 specificity results with confidence interval width≤5%, and lower for nucleic acid tests than antibody tests. Manufacturer-reported clinical performance was significantly higher than independently assessed in 11 of 32 and four of 34 cases, respectively, for sensitivity and specificity, indicating a need for improvement in this area. Conclusion: Continuous monitoring of clinical performance within more clearly defined target populations is needed.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationEuro Surveill. 2021 Nov;26(45):2001675. doi: 10.2807/1560-7917.ES.2021.26.45.2001675pt_PT
dc.identifier.doi10.2807/1560-7917.ES.2021.26.45.2001675pt_PT
dc.identifier.issn1560-7917
dc.identifier.urihttp://hdl.handle.net/10400.18/8231
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherEuropean Centre for Disease Prevention and Controlpt_PT
dc.relation.publisherversionhttps://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2021.26.45.2001675pt_PT
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/pt_PT
dc.subjectCOVID-19pt_PT
dc.subjectSARS-CoV-2pt_PT
dc.subjectDiagnosticpt_PT
dc.subjectAntibody Testspt_PT
dc.subjectAccuracypt_PT
dc.subjectMeta-analysispt_PT
dc.subjectSensitivitypt_PT
dc.subjectInfecções Respiratóriaspt_PT
dc.subjectInfecções Sistémicas e Zoonosespt_PT
dc.titleMeta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid and antibody tests up to 22 August 2020pt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue45pt_PT
oaire.citation.startPage2001675pt_PT
oaire.citation.titleEurosurveillancept_PT
oaire.citation.volume26pt_PT
rcaap.embargofctAcesso de acordo com política editorial da revista.pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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