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

Autor:	Bohn MK; Department of Paediatric Laboratory Medicine, CALIPER Program, The Hospital for Sick Children, Toronto, ON, Canada.; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada., Lippi G; University Hospital of Verona, Verona, Italy., Horvath AR; Department of Clinical Chemistry, NSW Health Pathology, Prince of Wales Hospital, Sydney, NSW, Australia., Erasmus R; Stellenbosch University, Cape Town, Western Cape, Republic of South Africa., Grimmler M; DiaSys Diagnostic Systems, Holzheim, Germany., Gramegna M; Sentinel CH. SpA, Milan, Italy., Mancini N; Vita-Salute San Raffaele University, Milan, Italy., Mueller R; Abbott Laboratories, Abbott Park, IL, USA., Rawlinson WD; Department of Virology, NSW Health Pathology, Prince of Wales Hospital, Sydney, NSW, Australia., Menezes ME; Secretaria de Saúde do Estado de Santa Catarina, Florianópolis, Brazil., Patru MM; Ortho Clinical Diagnostics, Raritan, NJ, USA., Rota F; Sentinel Diagnostics, Milan, Italy., Sethi S; National University Hospital, Singapore, Singapore., Singh K; Siemens Healthcare USA, Malvern, PA, USA., Yuen KY; University of Hong Kong, Hong Kong, P. R. China., Wang CB; Chinese PLA General Hospital, Beijing, P. R. China., Adeli K; Department of Paediatric Laboratory Medicine, CALIPER Program, The Hospital for Sick Children, Toronto, ON, Canada.; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
Jazyk:	angličtina
Zdroj:	Clinical chemistry and laboratory medicine [Clin Chem Lab Med] 2021 Apr 28; Vol. 59 (9), pp. 1507-1515. Date of Electronic Publication: 2021 Apr 28 (Print Publication: 2021).
DOI:	10.1515/cclm-2021-0455
Abstrakt:	With 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. (© 2021 Walter de Gruyter GmbH, Berlin/Boston.)
Databáze:	MEDLINE
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