Canadian Public Health Laboratory Network Statement on Point-of-Care Serology Testing in COVID-19

Abstract

Point-of-care (POC) serology tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), detect the human antibody response to infection or vaccination and not the virus itself. Most are qualitative immunochromatographic (lateral-flow)-based assays that detect IgG+/-IgM from a finger prick blood sample and can provide results in less than 30 minutes. While there is widespread interest in adopting POC serology tests for COVID-19, there are currently significant limitations to this testing modality, including the incomplete understanding of the immunological response in COVID-19, suboptimal clinical validation data, uncertain correlation (or lack thereof) with clinical laboratory-based serology tests and wide variability in performance among different POC tests. Many of the key points outlined below also apply to laboratory-based COVID-19 serology testing.