Abstract—Digital PCR (dPCR) is a nucleic acid quantification method that is widely used in genetic analysis. One of the most significant advantages of dPCR over other methods is the possibility of absolute quantitative determination of genetic material without construction of calibration curves, which allows one to detect even single molecules of nucleic acids, and, hence, provides early diagnosis of diseases. One specific characteristic of dPCR is the detection of the analyzed biological object in each microreaction, followed by the presentation of the analysis results in a binary system, thereby giving the method its name. The key aspects of developing the dPCR method, i.e., from the first devices based on microfluidic chip technology to modern systems capable of measuring a target at a concentration of up to 1 in 100 000 copies are shown in the current work. We analyzed the data on the detection of various pathogens using dPCR, as well as summarizing various study results demonstrating the innovativeness of this method. Both the possibilities of multiplex dPCR analysis and its potential in clinical practice are presented. This review also addresses the issue of the role of dPCR in the development of noninvasive methods for analysis of oncological diseases. Possible ways of developing dPCR technology were emphasized, including its use as a “point-of-care” system.

摘要—数字PCR（dPCR）是一种广泛应用于遗传分析的核酸定量方法。与其他方法相比，dPCR 的最显着优势之一是无需构建校准曲线即可对遗传物质进行绝对定量测定，这使得人们甚至可以检测单个核酸分子，从而提供疾病的早期诊断。dPCR 的一个具体特征是在每次微反应中检测所分析的生物对象，然后将分析结果呈现在二进制系统中，该方法因此而得名。开发 dPCR 方法的关键方面，即 目前的工作展示了从第一批基于微流控芯片技术的设备到能够测量浓度高达十万分之一的目标的现代系统。我们分析了使用 dPCR 检测各种病原体的数据，并总结了各种研究结果，证明了该方法的创新性。介绍了多重 dPCR 分析的可能性及其在临床实践中的潜力。本综述还讨论了 dPCR 在开发用于分析肿瘤疾病的非侵入性方法中的作用问题。强调了开发 dPCR 技术的可能方法，包括将其用作“即时护理”系统。并总结了各种研究结果，证明了该方法的创新性。介绍了多重 dPCR 分析的可能性及其在临床实践中的潜力。本综述还讨论了 dPCR 在开发用于分析肿瘤疾病的非侵入性方法中的作用问题。强调了开发 dPCR 技术的可能方法，包括将其用作“即时护理”系统。并总结了各种研究结果，证明了该方法的创新性。介绍了多重 dPCR 分析的可能性及其在临床实践中的潜力。本综述还讨论了 dPCR 在开发用于分析肿瘤疾病的非侵入性方法中的作用问题。强调了开发 dPCR 技术的可能方法，包括将其用作“即时护理”系统。