免疫分析是现代医学不可或缺的分析手段。现阶段的免疫技术大多存在检测限高、灵敏度低、复杂体系中可靠性差等问题，难以满足精准医疗的要求。单分子计数免疫分析也称为数字免疫分析，可通过计量免疫复合体个数进行定量，是一种超高灵敏免疫分析技术，能够满足重大疾病早期检测、血液中稀少抗原检测等高灵敏检测的需求。对单分子计数免疫分析的基础理论、分类方法、具体应用进行了介绍，重点阐述了国内外单分子计数免疫分析领域的研究现状，并对该免疫分析技术应用于医学临床诊断的前景进行了展望。

Immunoassay is an indispensable analytical method in modern medicine. At present, most immune technologies have the problems such as high detection limit, low sensitivity, and poor reliability in complex systems, which are difficult to meet the requirements of precision medicine. Single molecule immunoassay, also known as digital immunoassay, can quantify by measuring the number of immune complexes. It is an ultrahigh sensitive immunoassay technology, which can meet the needs of high sensitive detection such as early detection of major diseases and detection of rare antigens in blood. This paper introduces the basic theory, classification methods and specific applications of single molecule immunoassay, focuses on the research status in the field of single molecule counting immunoassay at home and abroad, and discusses the prospects of the applications of this immunoassay technology in medical clinical diagnosis.