单分子免疫阵列技术在传染病诊断中的应用

Application of Single Molecule Array in Diagnosis of Infectious Diseases

单分子免疫阵列(single molecule array,Simoa)技术,又称"数字ELISA",是近年来新开发的一种数字免疫分析方法,将单分子计数用于蛋白质生物标记物的检测。该方法可测量各种不同基质(血清、血浆、脑脊液、尿液、细胞提取物等)中的蛋白质,检测限可达飞摩尔(fg/mL)数量级,灵敏度较传统ELISA提高约1000倍。目前,该技术在一些重大传染病,如新冠肺炎、结核病、艾滋病、朊病毒病诊断中的优势逐渐凸显。Simoa技术可帮助监测新冠病毒感染进程,有望实现早期高灵敏度诊断,以区分新冠肺炎轻症和重症患者;有望帮助诊断活动性结核病,并可以监测结核病治疗效果;可更准确检测人免疫缺陷病毒(HIV)免疫相关蛋白含量变化,提高早期诊断的灵敏性;可在羊瘙痒病临床症状出现前检测活体动物血清,提高痒病早期检测能力,从而有望用于人类克雅氏症诊断。未来,通过开发相关病种的检测试剂盒,有望利用Simoa技术提高疫病的综合诊断能力,还可进行疫苗免疫效果评价,为疫病防控提供依据。

Single molecule array(Simoa),also known as"digital ELISA",was a new digital immunoassay technology developed in recent years,which was generally used to detect protein biomarkers via single molecule counting.The technology could be applied to measure proteins in various specimens,such as serum,plasma,cerebrospinal fluid,urine,cell extracts,etc.,with a limit of detection as low as femtomolar(fg/mL),and an approximately 1000-fold sensitivity compared to traditional ELISA.Currently,the technology was promisingly applied in diagnosis of some major infectious diseases including COVID-19,tuberculosis,AIDS and prion virus.As the process of COVID-19 infection could be monitored with the help of the technology,it was expected that,by the technology,such infection could be early diagnosed with high sensitivity so as to distinguish patients with severe or mild symptoms,so was the active tuberculosis,and relevant therapeutic effect could be monitored;any changes of relevant immunogenic protein content related to human immunodeficiency virus(HIV)could be accurately detected to improve the sensitivity of early diagnosis;serums of live animals could be detected prior to any clinical symptoms of scrapie to improve early detection capacity and then it was expected to be used in the diagnosis of human Creutzfeldt Jakob disease in the future.It was also expected that,through development of kits for corresponding diseases,the technology could be used to improve comprehensive diagnosis capacity,and evaluate the effect of vaccination to provide a basis for disease prevention and control.