IEEE Trans Nanobioscience. 2022 Jan;21(1):37-43. doi: 10.1109/TNB.2021.3105662. Epub 2021 Dec 30.
Coronavirus disease 2019 is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is highly transmissible. Early and rapid testing is necessary to effectively prevent and control the outbreak. Detection of SARS-CoV-2 antibodies with lateral flow immunoassay can achieve this goal. In this study, SARS-CoV-2 nucleoprotein (NP) was expressed and purified. We used the selenium nanoparticle as the labeling probe coupled with the NP to prepare an antibody (IgM and IgG) detection kit. The detection limit, cross reaction, sensitivity and specificity of the kit is verified. Separate detection of IgM and IgG, such as in this assay, was performed in order to reduce mutual interference and improve the accuracy of the test results.The final purity of NP was 91.83%. Selenium nanoparticle and NP successfully combined with stable effect. The LOD of the kit was 20 ng/mL for anti-NP IgG and 60 ng/mL for anti-NP IgM, respectively. The kit does not cross reaction with RF. The sensitivity of the kit was 94.74% and the specificity was 96.23%. The assay kit does not require any special device for reading the results and the readout is a simple color change that can be evaluated with the naked eye. This kit is suitable for rapid and real-time detection of the SARS-CoV-2 antibody IgG and IgM.
新型冠状病毒病 2019 是由严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）引起的传染病。SARS-CoV-2 具有高度传染性。早期和快速检测对于有效预防和控制疫情至关重要。侧向流动免疫分析检测 SARS-CoV-2 抗体可以实现这一目标。在本研究中，表达和纯化了 SARS-CoV-2 核衣壳蛋白（NP）。我们使用硒纳米颗粒作为标记探针，与 NP 结合，制备了一种抗体（IgM 和 IgG）检测试剂盒。验证了试剂盒的检测限、交叉反应、灵敏度和特异性。如该检测中分别检测 IgM 和 IgG，以减少相互干扰，提高检测结果的准确性。NP 的最终纯度为 91.83%。硒纳米颗粒和 NP 成功结合，效果稳定。试剂盒检测抗 NP IgG 的 LOD 为 20ng/mL，抗 NP IgM 的 LOD 为 60ng/mL。试剂盒与 RF 无交叉反应。试剂盒的灵敏度为 94.74%，特异性为 96.23%。该检测试剂盒不需要任何特殊的读数设备，结果的读取是简单的颜色变化，可以用肉眼评估。该试剂盒适用于 SARS-CoV-2 抗体 IgG 和 IgM 的快速实时检测。
