Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2
Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2
复制标题
基于核衣壳和刺突蛋白的 ELISA 检测 SARS-CoV-2 抗体的评估。
DOI：
10.1128/jcm.00461-20
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发表时间：
2020-06-01
影响因子：
9.4
通讯作者：
Zheng, Shangen
中科院分区：
文献类型：
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作者：
Liu, Wanbing;Liu, Lei;Zheng, Shangen
目前，基于PCR的核酸检测无法满足冠状病毒传染病（COVID-19）诊断的需求。招募了2020年1月18日至2月26日期间在中国人民解放军中部战区总医院住院的214名确诊COVID-19患者。采用基于重组SARS冠状病毒2型（SARS CoV-2）核衣壳蛋白（rN）和刺突蛋白（rS）的两种酶联免疫吸附试验（ELISA）试剂盒检测IgM和IgG抗体，并评价其诊断的可行性。在214例患者中，146例（68.2%）和150例（70.1%）分别成功地用基于rN的IgM和IgG ELISA诊断，165例（77.1%）和159例（74.3%）分别成功地用基于rS的IgM和IgG ELISA诊断。rN法和rS法检测IgM和/或IgG抗体的阳性率分别为80.4%和82.2%。rS-based ELISA检测IgM的灵敏度显著高于rN-based ELISA。我们观察到IgM和IgG的阳性率随着发病后天数（d.p.o.）的增加而增加，而IgM抗体阳性率在35 d后下降。rN和rS IgM和IgG ELISA在发病早期（0 ~ 10 d.p.o.）的阳性率均低于60%，免疫球蛋白IgM和IgG在10 d后明显升高。ELISA具有高灵敏度，特别是对于10 d.p.o.后患者的血清样品的检测，因此，它可能是COVID-19诊断的重要补充方法。
At present, PCR-based nucleic acid detection cannot meet the demands for coronavirus infectious disease (COVID-19) diagnosis. Two hundred fourteen confirmed COVID-19 patients who were hospitalized in the General Hospital of Central Theater Command of the People's Liberation Army between 18 January and 26 February 2020 were recruited. Two enzyme-linked immunosorbent assay (ELISA) kits based on recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid protein (rN) and spike protein (rS) were used for detecting IgM and IgG antibodies, and their diagnostic feasibility was evaluated. Among the 214 patients, 146 (68.2%) and 150 (70.1%) were successfully diagnosed with the rNbased IgM and IgG ELISAs, respectively; 165 (77.1%) and 159 (74.3%) were successfully diagnosed with the rS-based IgM and IgG ELISAs, respectively. The positive rates of the rN-based and rS-based ELISAs for antibody (IgM and/or IgG) detection were 80.4% and 82.2%, respectively. The sensitivity of the rS-based ELISA for IgM detection was significantly higher than that of the rN-based ELISA. We observed an increase in the positive rate for IgM and IgG with an increasing number of days post-disease onset (d.p.o.), but the positive rate of IgM dropped after 35 d.p.o. The positive rate of rN-based and rS-based IgM and IgG ELISAs was less than 60% during the early stage of the illness, 0 to 10 d.p.o., and that of IgM and IgG was obviously increased after 10 d.p.o. ELISA has a high sensitivity, especially for the detection of serum samples from patients after 10 d.p.o., so it could be an important supplementary method for COVID-19 diagnosis.