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

Jennifer Taher; Edward W Randell; Saranya Arnoldo; Dana Bailey; Vincent De Guire; Sukhbir Kaur; Michael Knauer; Eleonora Petryayeva; Susan M Poutanen; Julie L V Shaw; Uvaraj Uddayasankar; Nicole White-Al Habeeb; Danijela Konforte

doi:10.1016/j.clinbiochem.2021.05.010

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

Clin Biochem. 2021 Sep:95:1-12. doi: 10.1016/j.clinbiochem.2021.05.010. Epub 2021 May 25.

Authors

Affiliations

¹ Pathology and Laboratory Medicine, Sinai Health System, Toronto, Canada; University of Toronto, Laboratory Medicine and Pathobiology, Toronto, Canada.
² Department of Laboratory Medicine, Faculty of Medicine, Memorial University of Newfoundland, Newfoundland, Canada.
³ University of Toronto, Laboratory Medicine and Pathobiology, Toronto, Canada; William Osler Health System, Brampton, Canada.
⁴ Dynacare, Brampton, Canada.
⁵ Clinical Biochemistry, Maisonneuve-Rosemont Hospital, Optilab-CHUM Laboratory Network, Montreal, Canada; Biochemistry, Maisonneuve-Rosemont Hospital Research Centre, University of Montreal, Montreal, Canada.
⁶ Fraser Health Authority, Vancouver, Canada; Pathology and Laboratory Medicine, University of British Columbia, Canada.
⁷ Pathology and Laboratory Medicine, London Health Sciences Center, London, Canada; Pathology and Laboratory Medicine, University of Western Ontario, London, Canada.
⁸ Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Canada.
⁹ University of Toronto, Laboratory Medicine and Pathobiology, Toronto, Canada; University of Toronto, Medicine, Toronto, Canada; University Health Network/Sinai Health Department of Microbiology, Toronto, Canada.
¹⁰ Eastern Ontario Regional Laboratory Association, Canada; Department of Pathology and Laboratory Medicine, University of Ottawa, Ottawa, Canada.
¹¹ Lifelabs, Toronto, Canada.

Abstract

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.

Keywords: Antigen; COVID-19; Nucleic acid amplification test; Point-of-care testing; Quality management; SARS-CoV-2.

Publication types

Review

MeSH terms

COVID-19 / diagnosis*
COVID-19 / epidemiology
COVID-19 / genetics
Canada / epidemiology
Consensus*
Humans
Point-of-Care Testing / standards*
Practice Guidelines as Topic / standards*
Qualitative Research
Quality Improvement / standards
SARS-CoV-2 / genetics
SARS-CoV-2 / isolation & purification*
Societies, Scientific / standards*