Biomarkers Significance 6/10

Canadian Consensus Guidance on SARS-CoV-2 Serology Testing and Reporting

The Canadian Society of Clinical Chemists issued interim consensus guidance for SARS-CoV-2 antibody testing, covering assay performance, antibody kinetics, pediatric considerations, and point-of-care testing limitations. The document provided harmonized interpretive comments and reporting recommendations for clinical laboratories deploying commercial serology platforms. It served as a practical framework during the early pandemic when laboratories urgently needed standardized approaches to a novel analyte.

The original study

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

Authors
Bailey D, Konforte D, Barakauskas VE, Yip PM, Kulasingam V, Abou El Hassan M, et al.
Journal
Clinical biochemistry
Type
Journal Article, Review, Consensus Statement
PMID
33031819
Read the original study →

Original 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.