Duchesne L, Lacombe K
Sorbonne Universités, UPMC Univ Paris, Paris, France.
Inserm, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP UMRS 1136), Paris, France.
J Viral Hepat. 2018 Feb;25(2):108-117. doi: 10.1111/jvh.12827. Epub 2017 Dec 27.
According to the Global Burden of Diseases, chronic viral hepatitis B and C are one of the most challenging global health conditions that rank among the first causes of morbidity and mortality worldwide. Low- and middle-income countries are particularly affected by the health burden associated with HBV or HCV infection. One major gap in efficiently addressing the issue of viral hepatitis is universal screening. However, the costs and chronic lack of human resources for using traditional screening strategies based on serology and molecular biology preclude any scaling-up. Point-of-care tests have been deemed a powerful potential solution to fill the current diagnostics gap in low-resource and decentralized settings. Despite high interest resulting from their development in recent years, very few point-of-care devices have reached the market. Scaling down and automating all testing steps in 1 single device (eg, sample preparation, detection and readout) is indeed challenging. But innovations in multiple disciplines such as nanotechnologies, microfluidics, biosensors and synthetic biology have led to the creation of chip-sized laboratory systems called "lab-on-a-chip" devices. This review aims to explain how these innovations can overcome technological barriers that usually arise for each testing step while developing integrated point-of-care tests. Point-of-care test prototypes rarely meet the requirements for mass production, which also hinders their large-scale production. In addition to logistical hurdles, legal and economic constraints specific to the commercialization of in vitro diagnostics, which have also participated in the low transfer of innovative point-of-care tests to the field, are discussed.
根据《全球疾病负担》，慢性乙型和丙型病毒性肝炎是最具挑战性的全球健康问题之一，在全球发病率和死亡率的首要原因中名列前茅。低收入和中等收入国家尤其受到与乙肝病毒或丙肝病毒感染相关的健康负担的影响。有效解决病毒性肝炎问题的一个主要差距是普遍筛查。然而，使用基于血清学和分子生物学的传统筛查策略的成本以及长期缺乏人力资源阻碍了任何扩大规模的行动。即时检测被认为是填补低资源和分散环境中当前诊断差距的一个有力潜在解决方案。尽管近年来其发展引起了高度关注，但很少有即时检测设备进入市场。在一个单一设备中缩减并自动化所有检测步骤（例如样品制备、检测和读出）确实具有挑战性。但是纳米技术、微流控技术、生物传感器和合成生物学等多学科的创新导致了被称为“芯片实验室”设备的芯片大小的实验室系统的产生。这篇综述旨在解释这些创新如何在开发集成即时检测时克服每个检测步骤通常出现的技术障碍。即时检测原型很少满足大规模生产的要求，这也阻碍了它们的大规模生产。除了后勤障碍外，还讨论了体外诊断商业化特有的法律和经济限制，这些限制也导致了创新即时检测向实际应用的低转化率。
