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Article: IFCC interim guidelines on rapid point-of-care antigen testing for SARS-CoV-2 detection in asymptomatic and symptomatic individuals

TitleIFCC interim guidelines on rapid point-of-care antigen testing for SARS-CoV-2 detection in asymptomatic and symptomatic individuals
Authors
Keywordsasymptomatic individuals
laboratory-based immunoassays for SARS-CoV-2 detection
point-of-care immunoassays for SARS-CoV-2 detection
SARS-CoV-2 antigen rapid detection tests
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Issue Date2021
PublisherWalter de Gruyter GmbH & Co KG. The Journal's web site is located at http://www.degruyter.de/journals/cclm
Citation
Clinical Chemistry and Laboratory Medicine, 2021, v. 59 n. 9, p. 1507-1515 How to Cite?
AbstractWith an almost unremittent progression of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections all around the world, there is a compelling need to introduce rapid, reliable, and high-throughput testing to allow appropriate clinical management and/or timely isolation of infected individuals. Although nucleic acid amplification testing (NAAT) remains the gold standard for detecting and theoretically quantifying SARS-CoV-2 mRNA in various specimen types, antigen assays may be considered a suitable alternative, under specific circumstances. Rapid antigen tests are meant to detect viral antigen proteins in biological specimens (e.g. nasal, nasopharyngeal, saliva), to indicate current SARS-CoV-2 infection. The available assay methodology includes rapid chromatographic immunoassays, used at the point-of-care, which carries some advantages and drawbacks compared to more conventional, instrumentation-based, laboratory immunoassays. Therefore, this document by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Taskforce on COVID-19 aims to summarize available data on the performance of currently available SARS-CoV-2 antigen rapid detection tests (Ag-RDTs), providing interim guidance on clinical indications and target populations, assay selection, and evaluation, test interpretation and limitations, as well as on pre-analytical considerations. This document is hence mainly aimed to assist laboratory and regulated health professionals in selecting, validating, and implementing regulatory approved Ag-RDTs.
Persistent Identifierhttp://hdl.handle.net/10722/303987
ISSN
2023 Impact Factor: 3.8
2023 SCImago Journal Rankings: 1.081
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorBohn, MK-
dc.contributor.authorLippi, G-
dc.contributor.authorHorvath, AR-
dc.contributor.authorErasmus, R-
dc.contributor.authorGrimmler, M-
dc.contributor.authorGramegna, M-
dc.contributor.authorMancini, N-
dc.contributor.authorMueller, R-
dc.contributor.authorRawlinson, WD-
dc.contributor.authorMenezes, ME-
dc.contributor.authorPatru, MM-
dc.contributor.authorRota, F-
dc.contributor.authorSethi, S-
dc.contributor.authorSingh, K-
dc.contributor.authorYuen, KY-
dc.contributor.authorWang, CB-
dc.contributor.authorAdeli, K-
dc.date.accessioned2021-09-23T08:53:38Z-
dc.date.available2021-09-23T08:53:38Z-
dc.date.issued2021-
dc.identifier.citationClinical Chemistry and Laboratory Medicine, 2021, v. 59 n. 9, p. 1507-1515-
dc.identifier.issn1434-6621-
dc.identifier.urihttp://hdl.handle.net/10722/303987-
dc.description.abstractWith an almost unremittent progression of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections all around the world, there is a compelling need to introduce rapid, reliable, and high-throughput testing to allow appropriate clinical management and/or timely isolation of infected individuals. Although nucleic acid amplification testing (NAAT) remains the gold standard for detecting and theoretically quantifying SARS-CoV-2 mRNA in various specimen types, antigen assays may be considered a suitable alternative, under specific circumstances. Rapid antigen tests are meant to detect viral antigen proteins in biological specimens (e.g. nasal, nasopharyngeal, saliva), to indicate current SARS-CoV-2 infection. The available assay methodology includes rapid chromatographic immunoassays, used at the point-of-care, which carries some advantages and drawbacks compared to more conventional, instrumentation-based, laboratory immunoassays. Therefore, this document by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Taskforce on COVID-19 aims to summarize available data on the performance of currently available SARS-CoV-2 antigen rapid detection tests (Ag-RDTs), providing interim guidance on clinical indications and target populations, assay selection, and evaluation, test interpretation and limitations, as well as on pre-analytical considerations. This document is hence mainly aimed to assist laboratory and regulated health professionals in selecting, validating, and implementing regulatory approved Ag-RDTs.-
dc.languageeng-
dc.publisherWalter de Gruyter GmbH & Co KG. The Journal's web site is located at http://www.degruyter.de/journals/cclm-
dc.relation.ispartofClinical Chemistry and Laboratory Medicine-
dc.subjectasymptomatic individuals-
dc.subjectlaboratory-based immunoassays for SARS-CoV-2 detection-
dc.subjectpoint-of-care immunoassays for SARS-CoV-2 detection-
dc.subjectSARS-CoV-2 antigen rapid detection tests-
dc.subjectsevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-
dc.titleIFCC interim guidelines on rapid point-of-care antigen testing for SARS-CoV-2 detection in asymptomatic and symptomatic individuals-
dc.typeArticle-
dc.identifier.emailYuen, KY: kyyuen@hkucc.hku.hk-
dc.identifier.authorityYuen, KY=rp00366-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1515/cclm-2021-0455-
dc.identifier.pmid33908222-
dc.identifier.scopuseid_2-s2.0-85105325664-
dc.identifier.hkuros325586-
dc.identifier.volume59-
dc.identifier.issue9-
dc.identifier.spage1507-
dc.identifier.epage1515-
dc.identifier.isiWOS:000682134300013-
dc.publisher.placeGermany-

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