Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisation
Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisation
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DOI：
10.1016/j.jcv.2020.104512
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发表时间：
2020-08-01
影响因子：
8.8
通讯作者：
Lappalainen, M.
中科院分区：
文献类型：
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作者：
Jaaskelainen, A. J.;Kuivanen, S.;Lappalainen, M.
目前迫切需要可靠的高通量血清学检测方法来管理正在进行的COVID-19大流行。最好是用临床标本根据金标准（即病毒中和）来确定新型病毒的血清学检测的性能。我们比较了6种用于检测SARS-COV-2 IgG、IgA和IgM抗体的商业免疫检测方法的性能，包括4种自动检测方法[Abbott SARS-COV-2 IgG （CE标记）、Diasorin Liaison (R) SARS-COV-2 S1/S2 IgG（仅供研究使用，RUO）和euroimmune SARS-COV-2 IgG和IgA （CE标记）]。以及两项快速横向流动（免疫层图）检测[宏生物2019-nCoV IgG/IgM （CE标记）和厦门Biotime生物SARS-COV-2 IgG/IgM （CE标记）]和微量中和试验（MNT）。收集了送往赫尔辛基大学医院实验室（HUSLAB）的两份血清样本：患者组（N=70）包括PCR确诊的COVID-19患者的血清，阴性组（N=81）包括2018年和2019年用于自身免疫性疾病和呼吸道病毒抗体筛查的血清。对所有COVID-19样本（70份血清样本，62人）和阴性小组的53份样本进行了MNT检测。62名新冠肺炎患者中有41人出现了中和抗体。商用检测对MNT的特异性和敏感性分别为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% （euroimmune SARS-CoV-2 IgA）、86.6% / 70.7% （euroimmune SARS-CoV-2 IgG）、74.4% / 56.1% （Acro 2019-nCoV IgG）、69.5% / 46.3% （Acro 2019-nCoV IgM）、97.5% / 71.9%（厦门Biotime SARS-CoV-2 IgG）和88.8% / 81.3%（厦门Biotime SARS-CoV-2 IgM）。本研究显示了可变的性能值。实验室应仔细考虑其检测流程，例如采用双层方法，以优化SARS-CoV-2血清诊断的整体性能。
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 (R) 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. Fortyone out of62 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.