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. 2020 Oct 7;58(12):1993-2000.
doi: 10.1515/cclm-2020-1412.

IFCC Interim Guidelines on Molecular Testing of SARS-CoV-2 Infection

Mary Kathryn Bohn  1 , Nicasio Mancini  2 , Tze Ping Loh  3 , Cheng-Bin Wang  4 , Matthias Grimmler  5 , Maurizio Gramegna  6 , Kwok-Yung Yuen  7 , Robert Mueller  8 , David Koch  9 , Sunil Sethi  3 , William D Rawlinson  10 , Massimo Clementi  2 , Rajiv Erasmus  11 , Marc Leportier  12 , Gye Cheol Kwon  13 , María Elizabeth Menezes  14 , Maria-Magdalena Patru  15 , Krishna Singh  16 , Maurizio Ferrari  2 , Osama Najjar  17 , Andrea R Horvath  18 , Khosrow Adeli  1 , Giuseppe Lippi  19   20
Affiliations
Free article

IFCC Interim Guidelines on Molecular Testing of SARS-CoV-2 Infection

Mary Kathryn Bohn et al. Clin Chem Lab Med. .
Free article

Abstract

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.

Keywords: COVID-19; SARS-CoV-2; molecular testing; virology.

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