tetano
Editor, Senior Moderator
Clin Chem Lab Med
. 2020 Oct 7;/j/cclm.ahead-of-print/cclm-2020-1413/cclm-2020-1413.xml.
doi: 10.1515/cclm-2020-1413. Online ahead of print.
IFCC interim guidelines on serological testing of antibodies against SARS-CoV-2
Mary Kathryn Bohn[SUP] 1 2 3 [/SUP], Tze Ping Loh[SUP] 3 [/SUP], Cheng-Bin Wang[SUP] 4 [/SUP], Robert Mueller[SUP] 5 [/SUP], David Koch[SUP] 6 [/SUP], Sunil Sethi[SUP] 3 [/SUP], William D Rawlinson[SUP] 7 [/SUP], Massimo Clementi[SUP] 8 [/SUP], Rajiv Erasmus[SUP] 9 [/SUP], Marc Leportier[SUP] 10 [/SUP], Matthias Grimmler[SUP] 11 [/SUP], K Y Yuen[SUP] 12 [/SUP], Nicasio Mancini[SUP] 8 [/SUP], Gye Cheol Kwon[SUP] 13 [/SUP], Mar?a Elizabeth Menezes[SUP] 14 [/SUP], Maria-Magdalena Patru[SUP] 15 [/SUP], Maurizio Gramegna[SUP] 16 [/SUP], Krishna Singh[SUP] 17 [/SUP], Osama Najjar[SUP] 18 [/SUP], Maurizio Ferrari[SUP] 19 [/SUP], Andrea Horvath[SUP] 20 [/SUP], Giuseppe Lippi[SUP] 21 [/SUP], Khosrow Adeli[SUP] 1 2 22 23 [/SUP], Taskforce on COVID-19, International Federation of Clinical Chemistry (IFCC), Milan, Italy
Affiliations
Abstract
Serological testing for the detection of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is emerging as an important component of the clinical management of patients with coronavirus disease 2019 (COVID-19) as well as the epidemiological assessment of SARS-CoV-2 exposure worldwide. In addition to molecular testing for the detection of SARS-CoV-2 infection, clinical laboratories have also needed to increase testing capacity to include serological evaluation of patients with suspected or known COVID-19. While regulatory approved serological immunoassays are now widely available from diagnostic manufacturers globally, there is significant debate regarding the clinical utility of these tests, as well as their clinical and analytical performance requirements prior to application. This document by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Taskforce on COVID-19 provides interim guidance on: (A) clinical indications and target populations, (B) assay selection, (C) assay evaluation, and (D) test interpretation and limitations for serological testing of antibodies against SARS-CoV-2 infection. These evidence-based recommendations will provide practical guidance to clinical laboratories in the selection, verification, and implementation of serological assays and are of the utmost importance as we expand our pandemic response from initial case tracing and containment to mitigation strategies to minimize resurgence and further morbidity and mortality.
Keywords: COVID-19; SARS-CoV-2; antibody; immunity; laboratory medicine; serology.
. 2020 Oct 7;/j/cclm.ahead-of-print/cclm-2020-1413/cclm-2020-1413.xml.
doi: 10.1515/cclm-2020-1413. Online ahead of print.
IFCC interim guidelines on serological testing of antibodies against SARS-CoV-2
Mary Kathryn Bohn[SUP] 1 2 3 [/SUP], Tze Ping Loh[SUP] 3 [/SUP], Cheng-Bin Wang[SUP] 4 [/SUP], Robert Mueller[SUP] 5 [/SUP], David Koch[SUP] 6 [/SUP], Sunil Sethi[SUP] 3 [/SUP], William D Rawlinson[SUP] 7 [/SUP], Massimo Clementi[SUP] 8 [/SUP], Rajiv Erasmus[SUP] 9 [/SUP], Marc Leportier[SUP] 10 [/SUP], Matthias Grimmler[SUP] 11 [/SUP], K Y Yuen[SUP] 12 [/SUP], Nicasio Mancini[SUP] 8 [/SUP], Gye Cheol Kwon[SUP] 13 [/SUP], Mar?a Elizabeth Menezes[SUP] 14 [/SUP], Maria-Magdalena Patru[SUP] 15 [/SUP], Maurizio Gramegna[SUP] 16 [/SUP], Krishna Singh[SUP] 17 [/SUP], Osama Najjar[SUP] 18 [/SUP], Maurizio Ferrari[SUP] 19 [/SUP], Andrea Horvath[SUP] 20 [/SUP], Giuseppe Lippi[SUP] 21 [/SUP], Khosrow Adeli[SUP] 1 2 22 23 [/SUP], Taskforce on COVID-19, International Federation of Clinical Chemistry (IFCC), Milan, Italy
Affiliations
- PMID: 33027043
- DOI: 10.1515/cclm-2020-1413
Abstract
Serological testing for the detection of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is emerging as an important component of the clinical management of patients with coronavirus disease 2019 (COVID-19) as well as the epidemiological assessment of SARS-CoV-2 exposure worldwide. In addition to molecular testing for the detection of SARS-CoV-2 infection, clinical laboratories have also needed to increase testing capacity to include serological evaluation of patients with suspected or known COVID-19. While regulatory approved serological immunoassays are now widely available from diagnostic manufacturers globally, there is significant debate regarding the clinical utility of these tests, as well as their clinical and analytical performance requirements prior to application. This document by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Taskforce on COVID-19 provides interim guidance on: (A) clinical indications and target populations, (B) assay selection, (C) assay evaluation, and (D) test interpretation and limitations for serological testing of antibodies against SARS-CoV-2 infection. These evidence-based recommendations will provide practical guidance to clinical laboratories in the selection, verification, and implementation of serological assays and are of the utmost importance as we expand our pandemic response from initial case tracing and containment to mitigation strategies to minimize resurgence and further morbidity and mortality.
Keywords: COVID-19; SARS-CoV-2; antibody; immunity; laboratory medicine; serology.