Canadian society of clinical chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests

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

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.