多重核酸检测试验在综合征感染诊断中的应用日益增加。
The increasing application of multiplex nucleic acid detection tests to the diagnosis of syndromic infections.
机构信息
Norwich Medical School, University of East Anglia, NRP Innovation Centre, Norwich Research Park, Norwich, Norfolk, UK.
出版信息
Epidemiol Infect. 2014 Jan;142(1):1-11. doi: 10.1017/S0950268813002367. Epub 2013 Oct 7.
Abstract
On 14 January 2013, the US Food and Drug Administration (FDA) announced permission for a multiplex nucleic acid test, the xTAG® Gastrointestinal Pathogen Panel (GPP) (Luminex Corporation, USA), which simultaneously detects 11 common viral, bacterial and parasitic causes of infectious gastroenteritis, to be marketed in the USA. This announcement reflects the current move towards the development and commercialization of detection technologies based on nucleic acid amplification techniques for diagnosis of syndromic infections. We discuss the limitations and advantages of nucleic acid amplification techniques and the recent advances in Conformité Européene - in-vitro diagnostic (CE-IVD)-approved multiplex real-time PCR kits for the simultaneous detection of multiple targets within the clinical diagnostics market.
摘要
2013 年 1 月 14 日，美国食品和药物管理局（FDA）宣布批准一种多重核酸检测方法，即 xTAG® 胃肠道病原体检测试剂盒（GPP）（美国 Luminex 公司），用于在美国上市，这种试剂盒可以同时检测 11 种常见的引起传染性肠胃炎的病毒、细菌和寄生虫。这一消息反映了当前基于核酸扩增技术开发和商业化的趋势，用于综合征感染的诊断。我们讨论了核酸扩增技术的局限性和优势，以及最近在临床诊断市场中，经过欧盟符合性（CE-IVD）认证的多重实时 PCR 试剂盒的进展，这些试剂盒可以同时检测多个目标。
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2
Using procalcitonin-guided algorithms to improve antimicrobial therapy in ICU patients with respiratory infections and sepsis.应用降钙素原指导算法改善 ICU 呼吸感染和脓毒症患者的抗菌治疗。
Curr Opin Crit Care. 2013 Oct;19(5):453-60. doi: 10.1097/MCC.0b013e328363bd38.
3
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5
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6
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J Infect Dis. 2013 Aug 1;208(3):432-41. doi: 10.1093/infdis/jit190. Epub 2013 May 9.
7
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8
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