Canadian society of clinical chemists (CSCC) interim consensus guidance for testing and reporting of SARS-CoV-2 serology

Dana Bailey; Danijela Konforte; Vilte E Barakauskas; Paul M Yip; Vathany Kulasingam; Mohamed Abou El Hassan; Lori A Beach; Ivan M Blasutig; Peter Catomeris; Kent C Dooley; Yanping Gong; Peter Kavsak; Edward W Randell; Jason L Robinson; Julie Shaw; Jennifer Taher; Nicole White-Al Habeeb

doi:10.1016/j.clinbiochem.2020.09.005

Canadian society of clinical chemists (CSCC) interim consensus guidance for testing and reporting of SARS-CoV-2 serology

Clin Biochem. 2020 Dec:86:1-7. doi: 10.1016/j.clinbiochem.2020.09.005. Epub 2020 Oct 6.

Authors

Dana Bailey¹, Danijela Konforte², Vilte E Barakauskas³, Paul M Yip⁴, Vathany Kulasingam⁵, Mohamed Abou El Hassan⁶, Lori A Beach⁷, Ivan M Blasutig⁸, Peter Catomeris⁹, Kent C Dooley¹⁰, Yanping Gong¹¹, Peter Kavsak¹², Edward W Randell¹³, Jason L Robinson¹⁴, Julie Shaw¹⁵, Jennifer Taher¹⁶, Nicole White-Al Habeeb¹⁷

Affiliations

¹ Dynacare, Brampton, Canada. Electronic address: [email protected].
² LifeLabs, Toronto, Canada. Electronic address: [email protected].
³ Department of Pathology and Laboratory Medicine, BC Children's and Women's Hospital, Vancouver, Canada. Electronic address: [email protected].
⁴ Department of Laboratory Medicine and Molecular Diagnostics, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Canada. Electronic address: [email protected].
⁵ Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Canada; Department of Clinical Biochemistry, University Health Network, Toronto, Canada. Electronic address: [email protected].
⁶ LifeLabs, Toronto, Canada; Department of Pathology, Dalhousie University, Halifax, Canada. Electronic address: [email protected].
⁷ Department of Pathology, Dalhousie University, Halifax, Canada; Pathology and Laboratory Medicine, IWK Health Centre, Halifax, Canada. Electronic address: [email protected].
⁸ Eastern Ontario Regional Laboratory Association, Canada; CHEO, Ottawa, Canada; Department of Pathology and Laboratory Medicine, University of Ottawa, Ottawa, Canada. Electronic address: [email protected].
⁹ Dynacare, Brampton, Canada. Electronic address: [email protected].
¹⁰ Laboratory Medicine and Pathology, University of British Columbia, Vancouver, Canada; LifeLabs, Vancouver, Canada. Electronic address: [email protected].
¹¹ Pathology & Molecular Medicine, Queen's University, Kingston, Canada. Electronic address: [email protected].
¹² Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Canada. Electronic address: [email protected].
¹³ Department of Laboratory Medicine, Faculty of Medicine, Memorial University of Newfoundland, Newfoundland, Canada. Electronic address: [email protected].
¹⁴ Health PEI, Charlottetown, Canada. Electronic address: [email protected].
¹⁵ Eastern Ontario Regional Laboratory Association, Canada; Department of Pathology and Laboratory Medicine, University of Ottawa, Ottawa, Canada. Electronic address: [email protected].
¹⁶ Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Canada; Pathology & Laboratory Medicine, Mount Sinai Hospital, Toronto, Canada. Electronic address: [email protected].
¹⁷ LifeLabs, Toronto, Canada. Electronic address: [email protected].

Abstract

Clinical laboratories across the world are working to validate and perform testing for SARS-CoV-2 antibodies. Herein, we present interim consensus guidance for Canadian clinical laboratories testing and reporting SARS-CoV-2 serology, with emphasis on the capabilities and limitations of these tests and recommendations for interpretative comments in an effort to achieve harmonized laboratory practices. The consensus document provides a broad overview of topics including sample type and contamination risk; kinetics of antibody response to COVID-19 and the impact on serology testing; clinical utility of SARS-CoV-2 serology testing; clinical performance of commercial laboratory-based assays commonly deployed in North America; recommendations for interim reporting; utility of SARS-CoV-2 antibody testing for pediatric patients; and utility of point-of-care testing. The information is based on the current literature and is subject to change as additional information becomes available.

Keywords: Antibody; COVID-19; Clinical performance; Guidance document; SARS-CoV-2; Serology.

Publication types

Review

MeSH terms

COVID-19 Serological Testing*
COVID-19* / blood
COVID-19* / epidemiology
Canada
Chemistry, Pharmaceutical*
Consensus
Humans
Pandemics*
SARS-CoV-2*
Societies, Medical*