IFCC interim guidelines on molecular testing of SARS-CoV-2 infection.

Bohn, Mary Kathryn; Mancini, Nicasio; Loh, Tze Ping; Wang, Cheng-Bin; Grimmler, Matthias; Gramegna, Maurizio; Yuen, Kwok-Yung; Mueller, Robert; Koch, David; Sethi, Sunil; Rawlinson, William D; Clementi, Massimo; Erasmus, Rajiv; Leportier, Marc; Kwon, Gye Cheol; Menezes, María Elizabeth; Patru, Maria-Magdalena; Singh, Krishna; Ferrari, Maurizio; Najjar, Osama; Horvath, Andrea; Adeli, Khosrow; Lippi, Giuseppe

The diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection globally has relied extensively on molecular testing, contributing vitally to case identification, isolation, contact tracing, and rationalization of infection control measures during the coronavirus disease 2019 (COVID-19) pandemic. Clinical laboratories have thus needed to verify newly developed molecular tests and increase testing capacity at an unprecedented rate. As the COVID-19 pandemic continues to pose a global health threat, laboratories continue to encounter challenges in the selection, verification, and interpretation of these tests. This document by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on COVID-19 provides interim guidance on: (A) clinical indications and target populations, (B) assay selection, (C) assay verification, and (D) test interpretation and limitations for molecular testing of SARS-CoV-2 infection. These evidence-based recommendations will provide practical guidance to clinical laboratories worldwide and highlight the continued importance of laboratory medicine in our collective pandemic response.