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IFCC Interim Guidelines on Serological Testing of Antibodies against SARS-CoV-2.
Bohn, Mary Kathryn; Loh, Tze Ping; Wang, Cheng-Bin; Mueller, Robert; Koch, David; Sethi, Sunil; Rawlinson, William D; Clementi, Massimo; Erasmus, Rajiv; Leportier, Marc; Grimmler, Matthias; Yuen, K Y; Mancini, Nicasio; Kwon, Gye Cheol; Menezes, María Elizabeth; Patru, Maria-Magdalena; Gramegna, Maurizio; Singh, Krishna; Najjar, Osama; Ferrari, Maurizio; Horvath, Andrea R; Lippi, Giuseppe; Adeli, Khosrow.
  • Bohn MK; Paediatric Laboratory Medicine, The Hospital for Sick Children, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
  • Loh TP; National University Health System, Singapore, Singapore.
  • Wang CB; Chinese PLA General Hospital, Beijing, PR China.
  • Mueller R; Abbott Laboratories, Chicago, IL, USA.
  • Koch D; Emory University School of Medicine, Atlanta, GA, USA.
  • Sethi S; National University Health System, Singapore, Singapore.
  • Rawlinson WD; Virology Division, SEALS Microbiology, Prince of Wales Hospital, NSW, Randwick, Australia.
  • Clementi M; University Vita-Salute San Raffaele, Milan, Italy.
  • Erasmus R; University of Stellenbosch, Cape Town, Western Cape, Republic of South Africa.
  • Leportier M; Beckman Coulter Inc, Brea, CA, USA.
  • Grimmler M; DiaSys Diagnostic Systems, Holzheim, Germany.
  • Yuen KY; University of Hong Kong, Hong Kong, PR China.
  • Mancini N; University Vita-Salute San Raffaele, Milan, Italy.
  • Kwon GC; Chungnam National University Hospital, Daejeon, Republic of South Africa.
  • Menezes ME; Secretaria de Saúde do Estado de Santa Catarina, Florianópolis, Brazil.
  • Patru MM; Ortho Clinical Diagnostics, Raritan, NJ, USA.
  • Gramegna M; Sentinel CH. SpA, Milan, Italy.
  • Singh K; Siemens Healthcare USA, Malvern, PA, USA.
  • Najjar O; Allied Health Professions Ministry of Health, Palestine, Palestine.
  • Ferrari M; Universita Vita-Salute San Raffaele, Milano, Italy.
  • Horvath AR; Department of Clinical Chemistry, New South Wales Health Pathology, Prince of Wales Hospital, Sydney, NSW, Australia.
  • Lippi G; University Hospital of Verona, Verona, Italy.
  • Adeli K; Paediatric Laboratory Medicine, The Hospital for Sick Children, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
Clin Chem Lab Med ; 58(12): 2001-2008, 2020 10 07.
Article in English | MEDLINE | ID: covidwho-835981
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: International Agencies / Serologic Tests / Practice Guidelines as Topic / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: Clin Chem Lab Med Journal subject: Chemistry, Clinical / Laboratory Techniques and procedures Year: 2020 Document Type: Article Affiliation country: Cclm-2020-1413

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Full text: Available Collection: International databases Database: MEDLINE Main subject: International Agencies / Serologic Tests / Practice Guidelines as Topic / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: Clin Chem Lab Med Journal subject: Chemistry, Clinical / Laboratory Techniques and procedures Year: 2020 Document Type: Article Affiliation country: Cclm-2020-1413