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Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisation.
J Clin Virol. 2020 08; 129:104512.JC

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.

Authors+Show Affiliations

HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Finland. Electronic address: annemarjut.jaaskelainen@hus.fi.Department of Virology, University of Helsinki, Helsinki, Finland.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.HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Finland.HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Finland.HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Finland.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.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.HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Finland.HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Finland.

Pub Type(s)

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

Language

eng

PubMed ID

32563180

Citation

Jääskeläinen, A J., et al. "Performance of Six SARS-CoV-2 Immunoassays in Comparison With Microneutralisation." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 129, 2020, p. 104512.
Jääskeläinen AJ, Kuivanen S, Kekäläinen E, et al. Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisation. J Clin Virol. 2020;129:104512.
Jääskeläinen, A. J., Kuivanen, S., Kekäläinen, E., Ahava, M. J., Loginov, R., Kallio-Kokko, H., Vapalahti, O., Jarva, H., Kurkela, S., & Lappalainen, M. (2020). Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisation. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 129, 104512. https://doi.org/10.1016/j.jcv.2020.104512
Jääskeläinen AJ, et al. Performance of Six SARS-CoV-2 Immunoassays in Comparison With Microneutralisation. J Clin Virol. 2020;129:104512. PubMed PMID: 32563180.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisation. AU - Jääskeläinen,A J, AU - Kuivanen,S, AU - Kekäläinen,E, AU - Ahava,M J, AU - Loginov,R, AU - Kallio-Kokko,H, AU - Vapalahti,O, AU - Jarva,H, AU - Kurkela,S, AU - Lappalainen,M, Y1 - 2020/06/15/ PY - 2020/06/07/received PY - 2020/06/14/accepted PY - 2020/6/21/pubmed PY - 2020/8/12/medline PY - 2020/6/21/entrez KW - COVID-19 KW - IgA KW - IgG KW - Neutralisation KW - SARS-CoV-2 KW - Serology SP - 104512 EP - 104512 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 129 N2 - 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. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32563180/Performance_of_six_SARS_CoV_2_immunoassays_in_comparison_with_microneutralisation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30254-7 DB - PRIME DP - Unbound Medicine ER -