IFCC Interim Guidelines on Serological Testing of Antibodies against SARS-CoV-2.
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.
Keywords
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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