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Abstract：
We evaluated the diagnostic performance of newly developed microfluidic microplate-based fluorescent ELISA for anti-SARS-CoV-2 antibody detection: the Veri-Q opti COVID-19 IgG and IgM ELISAs (hereafter, \"Opti IgG/M\"; MiCo BioMed, Gyeonggi-do, Republic of Korea), in comparison with conventional ELISAs. A total of 270 serum samples were analyzed, among which 90 samples were serially obtained from 25 COVID-19 patients. Another 180 samples were collected from 180 SARS-CoV-2-negative individuals. As comparative assays, we used SCoV-2 Detect IgG/M ELISA (hereafter, \"InBios IgG/M\"; InBios, Seattle, WA, USA) and Veri-Q COVID-19 IgG/IgM ELISA (hereafter, \"Veri-Q IgG/M\"; MiCo BioMed). Compared with conventional ELISAs, the Opti IgG yielded 97.1-100.0% positive percent agreement, 95.2-98.0% negative percent agreement, 96.3-97.8% total percent agreement, and kappa values of 0.90-0.94. Between the Opti IgM and the InBios IgM, the values were 93.7%, 96.6%, 95.9%, and 0.89, respectively. For the Opti IgG, sensitivities for the samples collected from 0-7, 8-14, 15-21, and ≥ 22 days after symptom onset were 40.0, 58.3, 94.1, and 100.0%, respectively. The values for the Opti IgM were 30.0, 54.2, 88.2, and 80%, respectively. The diagnostic specificities of the Opti IgG and IgM were 99.4 and 97.2%, respectively. The microfluidic microplate-based fluorescent ELISAs showed comparable diagnostic performance to conventional ELISAs for detecting anti-SARS-CoV-2 antibodies. With the combination of high throughput, a simplified workflow, and the ability to analyze reduced volumes, this new technology has great potential for improving SARS-CoV-2 serologic testing.
摘要：
我们评估了新开发的基于微流控微孔板的荧光ELISA用于抗SARS-CoV-2抗体检测的诊断性能：Veri-QoptiCOVID-19IgG和IgMELISA（以下，“OptiIgG/M”；MiCoBioMed，京夷道,大韩民国),与传统的ELISA相比。共分析了270份血清样本,其中90份样本来自25例COVID-19患者。从180名SARS-CoV-2阴性个体中收集了另外180个样品。作为比较试验，我们使用SCoV-2检测IgG/MELISA(以下，“InBiosIgG/M”；InBios，西雅图,WA,美国)和Veri-QCOVID-19IgG/IgMELISA(以下称，“Veri-QIgG/M”；MiCoBioMed）。与常规ELISA相比,OptiIgG产生97.1-100.0%的正百分比一致性，95.2-98.0%负百分比协议，96.3-97.8%的总百分比协议，和kappa值为0.90-0.94。在OptiIgM和InBiosIgM之间，数值为93.7%,96.6%,95.9%,和0.89。对于OptiIgG，从症状发作后0-7、8-14、15-21和≥22天收集的样品的敏感性分别为40.0、58.3、94.1和100.0％，分别。OptiIgM的值分别为30.0、54.2、88.2和80%，分别。OptiIgG和IgM的诊断特异性分别为99.4％和97.2％，分别。基于微流体微孔板的荧光ELISA显示出与常规ELISA相当的诊断性能，用于检测抗SARS-CoV-2抗体。结合高吞吐量，简化的工作流程，以及分析减少体积的能力，这项新技术在改善SARS-CoV-2血清学检测方面具有巨大潜力。
