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

•SARS-CoV-2 serology offers limited clinical utility for individuals.•SARS-CoV-2 serology may be useful for seroprevalence studies.•Claims regarding protective immunity or infectivity cannot be made using serology.•Assay clinical sensitivity and specificity should approach 100%.•Harmonized reporting...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Clinical biochemistry 2020-12, Vol.86, p.1-7
Hauptverfasser: Bailey, Dana, Konforte, Danijela, Barakauskas, Vilte E., Yip, Paul M., Kulasingam, Vathany, Abou El Hassan, Mohamed, Beach, Lori A., Blasutig, Ivan M., Catomeris, Peter, Dooley, Kent C., Gong, Yanping, Kavsak, Peter, Randell, Edward W., Robinson, Jason L., Shaw, Julie, Taher, Jennifer, White-Al Habeeb, Nicole
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung:•SARS-CoV-2 serology offers limited clinical utility for individuals.•SARS-CoV-2 serology may be useful for seroprevalence studies.•Claims regarding protective immunity or infectivity cannot be made using serology.•Assay clinical sensitivity and specificity should approach 100%.•Harmonized reporting of SARS-CoV-2 serology minimizes result misinterpretation. 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.
ISSN:0009-9120
1873-2933
1873-2933
DOI:10.1016/j.clinbiochem.2020.09.005