Woodworth Michael H, Neish Emma M, Miller Nancy S, Dhere Tanvi, Burd Eileen M, Carpentieri Cynthia, Sitchenko Kaitlin L, Kraft Colleen S
Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.
Emory University, Atlanta, Georgia, USA.
J Clin Microbiol. 2017 Apr;55(4):1002-1010. doi: 10.1128/JCM.02327-16. Epub 2017 Jan 11.
Fecal microbiota transplantation is an efficacious and inexpensive therapy for recurrent infection, yet its safety is thought to depend on appropriate fecal donor screening. FDA guidance for regulation of this procedure is in flux, but screening and manufacture of fecal material from asymptomatic donors present many challenges to clinical laboratories. This minireview summarizes FDA regulatory changes, principles of donor selection, and recommended laboratory screening practices for fecal microbiota transplantation.
粪便微生物群移植是一种治疗复发性感染的有效且廉价的疗法，但其安全性被认为取决于对粪便供体的适当筛选。美国食品药品监督管理局（FDA）对该程序的监管指南正在不断变化，但对无症状供体粪便材料的筛选和制备给临床实验室带来了诸多挑战。本综述总结了FDA的监管变化、供体选择原则以及粪便微生物群移植推荐的实验室筛选方法。
