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

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.

Fig. 1

Schematic of the antigenic targets of commercial SARS-CoV-2 antibody assays. The list of assays is not exhaustive and reflects the instruments commonly used in Canadian clinical laboratories. At this time, not all assays listed have received Health Canada in vitro diagnostic device licensing.