Engstrom-Melnyk Julia, Rodriguez Pedro L, Peraud Olivier, Hein Raymond C
Medical and Scientific Affairs, Roche Diagnostic Corporation, Indianapolis, Indiana, USA.
Methods Microbiol. 2015;42:161-197. doi: 10.1016/bs.mim.2015.04.005. Epub 2015 Jul 7.
Since the invention of the polymerase chain reaction (PCR) and discovery of polymerase, PCR has become a staple in both research and clinical molecular laboratories. As clinical and diagnostic needs have evolved over the last few decades, demanding greater levels of sensitivity and accuracy, so too has PCR performance. Through optimisation, the present-day uses of real-time PCR and quantitative real-time PCR are enumerable. The technique, combined with adoption of automated processes and reduced sample volume requirements, makes it an ideal method in a broad range of clinical applications, especially in virology. Complementing serologic testing by detecting infections within the pre-seroconversion window period and infections with immunovariant viruses, real-time PCR provides a highly valuable tool for screening, diagnosing, or monitoring diseases, as well as evaluating medical and therapeutic decision points that allows for more timely predictions of therapeutic failures than traditional methods and, lastly, assessing cure rates following targeted therapies. All of these serve vital roles in the continuum of care to enhance patient management. Beyond this, quantitative real-time PCR facilitates advancements in the quality of diagnostics by driving consensus management guidelines following standardisation to improve patient outcomes, pushing for disease eradication with assays offering progressively lower limits of detection, and rapidly meeting medical needs in cases of emerging epidemic crises involving new pathogens that may result in significant health threats.
自从聚合酶链反应（PCR）发明以及聚合酶被发现以来，PCR已成为研究和临床分子实验室的常用技术。在过去几十年中，随着临床和诊断需求的不断演变，对灵敏度和准确性的要求越来越高，PCR的性能也随之提升。通过优化，实时PCR和定量实时PCR如今的应用不胜枚举。该技术结合自动化流程以及对样本量要求的降低，使其成为广泛临床应用中的理想方法，尤其是在病毒学领域。实时PCR通过在血清转化前窗口期检测感染以及免疫变异病毒感染来补充血清学检测，为疾病的筛查、诊断或监测，以及评估医疗和治疗决策点提供了极具价值的工具，与传统方法相比，它能更及时地预测治疗失败，最后还能评估靶向治疗后的治愈率。所有这些在连续的医疗护理中都发挥着至关重要的作用，以加强患者管理。除此之外，定量实时PCR通过推动标准化后的共识管理指南来改善患者预后，利用检测限不断降低的检测方法推动疾病根除，并在涉及可能导致重大健康威胁的新病原体的新兴疫情危机中迅速满足医疗需求，从而促进诊断质量的提升。
