tetano
Editor, Senior Moderator
Clin Chem Lab Med
. 2020 Oct 7;/j/cclm.ahead-of-print/cclm-2020-1412/cclm-2020-1412.xml.
doi: 10.1515/cclm-2020-1412. Online ahead of print.
IFCC interim guidelines on molecular testing of SARS-CoV-2 infection
Mary Kathryn Bohn[SUP] 1 2 [/SUP], Nicasio Mancini[SUP] 3 [/SUP], Tze Ping Loh[SUP] 4 [/SUP], Cheng-Bin Wang[SUP] 5 [/SUP], Matthias Grimmler[SUP] 6 [/SUP], Maurizio Gramegna[SUP] 7 [/SUP], Kwok-Yung Yuen[SUP] 8 [/SUP], Robert Mueller[SUP] 9 [/SUP], David Koch[SUP] 10 [/SUP], Sunil Sethi[SUP] 4 [/SUP], William D Rawlinson[SUP] 11 [/SUP], Massimo Clementi[SUP] 3 [/SUP], Rajiv Erasmus[SUP] 12 [/SUP], Marc Leportier[SUP] 13 [/SUP], Gye Cheol Kwon[SUP] 14 [/SUP], Mar?a Elizabeth Menezes[SUP] 15 [/SUP], Maria-Magdalena Patru[SUP] 16 [/SUP], Krishna Singh[SUP] 17 [/SUP], Maurizio Ferrari[SUP] 3 [/SUP], Osama Najjar[SUP] 18 [/SUP], Andrea Horvath[SUP] 19 [/SUP], Khosrow Adeli[SUP] 1 2 [/SUP], Giuseppe Lippi[SUP] 20 21 [/SUP]
Affiliations
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.
. 2020 Oct 7;/j/cclm.ahead-of-print/cclm-2020-1412/cclm-2020-1412.xml.
doi: 10.1515/cclm-2020-1412. Online ahead of print.
IFCC interim guidelines on molecular testing of SARS-CoV-2 infection
Mary Kathryn Bohn[SUP] 1 2 [/SUP], Nicasio Mancini[SUP] 3 [/SUP], Tze Ping Loh[SUP] 4 [/SUP], Cheng-Bin Wang[SUP] 5 [/SUP], Matthias Grimmler[SUP] 6 [/SUP], Maurizio Gramegna[SUP] 7 [/SUP], Kwok-Yung Yuen[SUP] 8 [/SUP], Robert Mueller[SUP] 9 [/SUP], David Koch[SUP] 10 [/SUP], Sunil Sethi[SUP] 4 [/SUP], William D Rawlinson[SUP] 11 [/SUP], Massimo Clementi[SUP] 3 [/SUP], Rajiv Erasmus[SUP] 12 [/SUP], Marc Leportier[SUP] 13 [/SUP], Gye Cheol Kwon[SUP] 14 [/SUP], Mar?a Elizabeth Menezes[SUP] 15 [/SUP], Maria-Magdalena Patru[SUP] 16 [/SUP], Krishna Singh[SUP] 17 [/SUP], Maurizio Ferrari[SUP] 3 [/SUP], Osama Najjar[SUP] 18 [/SUP], Andrea Horvath[SUP] 19 [/SUP], Khosrow Adeli[SUP] 1 2 [/SUP], Giuseppe Lippi[SUP] 20 21 [/SUP]
Affiliations
- PMID: 33027042
- DOI: 10.1515/cclm-2020-1412
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.