Canadian Society of Clinical Chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests

OBJECTIVES: A consensus guidance is provided for testing, utility and verification of SARS-CoV-2 point-of-care test (POCT) performance and implementation of a quality management program, focusing on nucleic acid and antigen targeted technologies. DESIGN AND METHODS: The recommendations are based on...

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Autores principales: Taher, Jennifer, Randell, Edward W., Arnoldo, Saranya, Bailey, Dana, De Guire, Vincent, Kaur, Sukhbir, Knauer, Michael, Petryayeva, Eleonora, Poutanen, Susan M., Shaw, Julie L.V., Uddayasankar, Uvaraj, White-Al Habeeb, Nicole, Konforte, Danijela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Canadian Society of Clinical Chemists. Published by Elsevier Inc. 2021
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8144094/
https://www.ncbi.nlm.nih.gov/pubmed/34048776
http://dx.doi.org/10.1016/j.clinbiochem.2021.05.010
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author Taher, Jennifer
Randell, Edward W.
Arnoldo, Saranya
Bailey, Dana
De Guire, Vincent
Kaur, Sukhbir
Knauer, Michael
Petryayeva, Eleonora
Poutanen, Susan M.
Shaw, Julie L.V.
Uddayasankar, Uvaraj
White-Al Habeeb, Nicole
Konforte, Danijela
author_facet Taher, Jennifer
Randell, Edward W.
Arnoldo, Saranya
Bailey, Dana
De Guire, Vincent
Kaur, Sukhbir
Knauer, Michael
Petryayeva, Eleonora
Poutanen, Susan M.
Shaw, Julie L.V.
Uddayasankar, Uvaraj
White-Al Habeeb, Nicole
Konforte, Danijela
author_sort Taher, Jennifer
collection PubMed
description OBJECTIVES: A consensus guidance is provided for testing, utility and verification of SARS-CoV-2 point-of-care test (POCT) performance and implementation of a quality management program, focusing on nucleic acid and antigen targeted technologies. DESIGN AND METHODS: The recommendations are based on current literature and expert opinion from the members of Canadian Society of Clinical Chemists (CSCC), and are intended for use inside or outside of healthcare settings that have varied levels of expertise and experience with POCT. RESULTS AND CONCLUSIONS: Here we discuss sampling requirements, biosafety, SARS-CoV-2 point-of-care testing methodologies (with focus on Health Canada approved tests), test performance and limitations, test selection, testing utility, development and implementation of quality management systems, quality improvement, and medical and scientific oversight.
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spelling pubmed-81440942021-05-25 Canadian Society of Clinical Chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests Taher, Jennifer Randell, Edward W. Arnoldo, Saranya Bailey, Dana De Guire, Vincent Kaur, Sukhbir Knauer, Michael Petryayeva, Eleonora Poutanen, Susan M. Shaw, Julie L.V. Uddayasankar, Uvaraj White-Al Habeeb, Nicole Konforte, Danijela Clin Biochem Article OBJECTIVES: A consensus guidance is provided for testing, utility and verification of SARS-CoV-2 point-of-care test (POCT) performance and implementation of a quality management program, focusing on nucleic acid and antigen targeted technologies. DESIGN AND METHODS: The recommendations are based on current literature and expert opinion from the members of Canadian Society of Clinical Chemists (CSCC), and are intended for use inside or outside of healthcare settings that have varied levels of expertise and experience with POCT. RESULTS AND CONCLUSIONS: Here we discuss sampling requirements, biosafety, SARS-CoV-2 point-of-care testing methodologies (with focus on Health Canada approved tests), test performance and limitations, test selection, testing utility, development and implementation of quality management systems, quality improvement, and medical and scientific oversight. The Canadian Society of Clinical Chemists. Published by Elsevier Inc. 2021-09 2021-05-25 /pmc/articles/PMC8144094/ /pubmed/34048776 http://dx.doi.org/10.1016/j.clinbiochem.2021.05.010 Text en © 2021 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Taher, Jennifer
Randell, Edward W.
Arnoldo, Saranya
Bailey, Dana
De Guire, Vincent
Kaur, Sukhbir
Knauer, Michael
Petryayeva, Eleonora
Poutanen, Susan M.
Shaw, Julie L.V.
Uddayasankar, Uvaraj
White-Al Habeeb, Nicole
Konforte, Danijela
Canadian Society of Clinical Chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests
title Canadian Society of Clinical Chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests
title_full Canadian Society of Clinical Chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests
title_fullStr Canadian Society of Clinical Chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests
title_full_unstemmed Canadian Society of Clinical Chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests
title_short Canadian Society of Clinical Chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests
title_sort canadian society of clinical chemists (cscc) consensus guidance for testing, selection and quality management of sars-cov-2 point-of-care tests
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8144094/
https://www.ncbi.nlm.nih.gov/pubmed/34048776
http://dx.doi.org/10.1016/j.clinbiochem.2021.05.010
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