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IFCC interim guidelines on rapid point-of-care antigen testing for SARS-CoV-2 detection in asymptomatic and symptomatic individuals.
- Source :
-
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). - Publication Year :
- 2021
-
Abstract
- 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.<br /> (© 2021 Walter de Gruyter GmbH, Berlin/Boston.)
Details
- Language :
- English
- ISSN :
- 1437-4331
- Volume :
- 59
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Clinical chemistry and laboratory medicine
- Publication Type :
- Academic Journal
- Accession number :
- 33908222
- Full Text :
- https://doi.org/10.1515/cclm-2021-0455