Keck Graduate Institute of Applied Life Sciences, 535 Watson Drive, Claremont, CA 91711, USA.
Expert Rev Mol Diagn. 2012 Sep;12(7):687-701. doi: 10.1586/erm.12.71.
Early diagnosis of tuberculosis (TB) facilitates appropriate treatment initiation and can limit the spread of this highly contagious disease. However, commonly used TB diagnostic methods are slow, often insensitive, cumbersome and inaccessible to most patients in TB endemic countries that lack necessary resources. This review discusses nucleic acid amplification technologies, which are being developed for rapid near patient TB diagnosis, that are in the market or undergoing clinical evaluation. They are based on PCR or isothermal methods and are implemented as manual assays or partially/fully integrated instrument systems, with associated tradeoffs between clinical performance, cost, robustness, quality assurance and usability in remote settings by minimally trained personnel. Unmet needs prevail for the identification of drug-resistant TB and for TB diagnosis in HIV-positive and pediatric patients.
早期诊断结核病（TB）有助于及时开始适当的治疗，并可限制这种高度传染性疾病的传播。然而，在资源匮乏的结核病流行国家，常用的结核病诊断方法速度缓慢，往往不敏感，繁琐且大多数患者无法获得。本文讨论了正在开发中的用于快速现场诊断结核病的核酸扩增技术，这些技术已经上市或正在进行临床评估。它们基于 PCR 或等温方法，并作为手动检测或部分/完全集成的仪器系统实施，在临床性能、成本、稳健性、质量保证以及在由训练有素的人员操作的远程环境中的可用性之间存在权衡。耐药结核病的鉴定和 HIV 阳性及儿科患者的结核病诊断仍然存在未满足的需求。
