Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisation

A J Jääskeläinen; S Kuivanen; E Kekäläinen; M J Ahava; R Loginov; H Kallio-Kokko; O Vapalahti; H Jarva; S Kurkela; M Lappalainen

doi:10.1016/j.jcv.2020.104512

Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisation

J Clin Virol. 2020 Aug:129:104512. doi: 10.1016/j.jcv.2020.104512. Epub 2020 Jun 15.

Authors

A J Jääskeläinen¹, S Kuivanen², E Kekäläinen³, M J Ahava⁴, R Loginov⁴, H Kallio-Kokko⁴, O Vapalahti⁵, H Jarva³, S Kurkela⁴, M Lappalainen⁴

Affiliations

¹ HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Finland. Electronic address: annemarjut.jaaskelainen@hus.fi.
² Department of Virology, University of Helsinki, Helsinki, Finland.
³ HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Finland; Translational Immunology Research Program and Department of Bacteriology and Immunology, University of Helsinki, Helsinki, Finland.
⁴ HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Finland.
⁵ HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Finland; Department of Virology, University of Helsinki, Helsinki, Finland; Depts of Virology and Veterinary Biosciences, University of Helsinki, Helsinki, Finland.

Abstract

There is an urgent need for reliable high-throughput serological assays for the management of the ongoing COVID-19 pandemic. Preferably, the performance of serological tests for a novel virus should be determined with clinical specimens against a gold standard, i.e. virus neutralisation. We compared the performance of six commercial immunoassays for the detection of SARS-COV-2 IgG, IgA and IgM antibodies, including four automated assays [Abbott SARS-COV-2 IgG (CE marked), Diasorin Liaison® SARS-COV-2 S1/S2 IgG (research use only, RUO), and Euroimmun SARS-COV-2 IgG and IgA (CE marked)], and two rapid lateral flow (immunocromatographic) tests [Acro Biotech 2019-nCoV IgG/IgM (CE marked) and Xiamen Biotime Biotechnology SARS-COV-2 IgG/IgM (CE marked)] with a microneutralisation test (MNT). Two specimen panels from serum samples sent to Helsinki University Hospital Laboratory (HUSLAB) were compiled: the patient panel (N=70) included sera from PCR confirmed COVID-19 patients, and the negative panel (N=81) included sera sent for screening of autoimmune diseases and respiratory virus antibodies in 2018 and 2019. The MNT was carried out for all COVID-19 samples (70 serum samples, 62 individuals) and for 53 samples from the negative panel. Forty-one out of 62 COVID-19 patients showed neutralising antibodies.The specificity and sensitivity values of the commercial tests against MNT, respectively, were as follows: 95.1 %/80.5 % (Abbott Architect SARS-CoV-2 IgG), 94.9 %/43.8 % (Diasorin Liaison SARS-CoV-2 IgG; RUO), 68.3 %/87.8 % (Euroimmun SARS-CoV-2 IgA), 86.6 %/70.7 % (Euroimmun SARS-CoV-2 IgG), 74.4 %/56.1 % (Acro 2019-nCoV IgG), 69.5 %/46.3 % (Acro 2019-nCoV IgM), 97.5 %/71.9 % (Xiamen Biotime SARS-CoV-2 IgG), and 88.8 %/81.3 % (Xiamen Biotime SARS-CoV-2 IgM). This study shows variable performance values. Laboratories should carefully consider their testing process, such as a two-tier approach, in order to optimize the overall performance of SARS- CoV-2 serodiagnostics.

Keywords: COVID-19; IgA; IgG; Neutralisation; SARS-CoV-2; Serology.

Publication types

Comparative Study
Evaluation Study
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Adult
Aged
Aged, 80 and over
Antibodies, Viral / blood*
Automation, Laboratory / methods
Betacoronavirus / immunology*
COVID-19
COVID-19 Testing
Child
Child, Preschool
Clinical Laboratory Techniques / methods*
Coronavirus Infections / diagnosis*
Female
Hospitals
Humans
Immunoassay / methods
Immunoglobulin A / blood
Immunoglobulin G / blood
Immunoglobulin M / blood
Male
Middle Aged
Neutralization Tests / methods*
Pandemics
Pneumonia, Viral / diagnosis*
SARS-CoV-2
Sensitivity and Specificity
Serologic Tests / methods*
Young Adult

Substances

Antibodies, Viral
Immunoglobulin A
Immunoglobulin G
Immunoglobulin M