Department of Chemistry and Institutes of Biomedical Sciences, Fudan University, Shanghai, 200433, PR China.
Department of Laboratory Medicine, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, 200123, PR China.
Anal Chim Acta. 2021 Dec 1;1187:339144. doi: 10.1016/j.aca.2021.339144. Epub 2021 Oct 5.
A simple, rapid and robust method to quantify SARS-CoV-2 neutralizing antibodies (nAbs) is urgently needed for determining COVID-19 serodiagnosis, vaccine development and evaluation of vaccine efficacy. In this study, we report sandwich/competitive immuno-sensors based on lateral chromatography micro-interface for accurate quantification of SARS-CoV-2 nAbs. Fluorescent microspheres (FMS) labeled receptor binding domain (RBD) antigen was prepared for detection of nAbs with high sensitivity. Sandwich and competitive immunoassay were conducted on the microfluidic-based sensor within 10 min and the fluorescent signal of immunoassay was analyzed by a portable microfluidic immunoassay instrument. The nAbs detection range of sandwich immuno-sensor and competitive immuno-sensor was 4.0 ng/mL to 400 ng/mL and 2.13 ng/mL to 213 ng/mL, respectively. Furthermore, the sandwich immuno-sensor was demonstrated to be comparable with existing methods and used to detect 182 clinical serum samples from vaccinated individuals. Sandwich immuno-sensor based on lateral chromatography micro-interface allowed reliable, fast, and low-cost detection of nAbs, which holds considerable potential for nAbs testing.
一种简单、快速和稳健的方法来定量 SARS-CoV-2 中和抗体（nAbs），对于确定 COVID-19 的血清学诊断、疫苗开发和评估疫苗效果是非常必要的。在本研究中，我们报告了基于横向流微界面的夹心/竞争性免疫传感器，用于准确定量 SARS-CoV-2 nAbs。荧光微球（FMS）标记的受体结合域（RBD）抗原被制备用于高灵敏度检测 nAbs。夹心和竞争性免疫测定在基于微流控的传感器上在 10 分钟内完成，免疫测定的荧光信号通过便携式微流控免疫分析仪器进行分析。夹心免疫传感器和竞争性免疫传感器的 nAbs 检测范围分别为 4.0ng/mL 至 400ng/mL 和 2.13ng/mL 至 213ng/mL。此外，夹心免疫传感器被证明与现有方法相当，并用于检测 182 份来自接种个体的临床血清样本。基于横向流微界面的夹心免疫传感器允许可靠、快速和低成本的 nAbs 检测，这对于 nAbs 测试具有相当大的潜力。
