Wickes Brian L, Romanelli Anna M
Department of Microbiology, Immunology, and Molecular Genetics, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA
Department of Pathology and Laboratory Medicine, University of California, Davis Health System, Sacramento, California, USA.
J Clin Microbiol. 2020 Mar 25;58(4). doi: 10.1128/JCM.01345-19.
Developing any diagnostic assay that receives United States Food and Drug Administration (FDA) approval can be a slow and difficult process. FDA-approved assays for fungal diagnosis are generally few in number and are focused mainly on diagnosing candidiasis, which is caused by several species of , in addition to a limited number of systemic mycotic agents. While all microbial diagnostic assays face challenges before they are FDA approved and reach the market, there are a number of challenges to fungal diagnostic assay development that have been difficult hurdles to overcome. These hurdles include template preparation, fungal morphology, how many fungi should be identified in a single assay (scope), taxonomy and nomenclature, discriminating colonizers from invasive infection, combining identification with antifungal susceptibility, and navigating the administrative hurdles required to integrate an assay into a clinical laboratory. Some of these challenges are easier to overcome than others, but all seem to be particularly difficult for fungal diagnostic assays.
开发任何获得美国食品药品监督管理局（FDA）批准的诊断检测方法都可能是一个缓慢而艰难的过程。FDA批准的用于真菌诊断的检测方法通常数量较少，主要集中于诊断念珠菌病，念珠菌病由多种念珠菌引起，此外还包括数量有限的系统性真菌病原体。虽然所有微生物诊断检测方法在获得FDA批准并推向市场之前都会面临挑战，但真菌诊断检测方法的开发存在一些难以克服的挑战。这些障碍包括模板制备、真菌形态学、单次检测应鉴定多少种真菌（检测范围）、分类学和命名法、区分定植菌与侵袭性感染、将鉴定与抗真菌药敏试验相结合，以及应对将检测方法整合到临床实验室所需的管理障碍。其中一些挑战比其他挑战更容易克服，但对于真菌诊断检测方法来说，似乎所有挑战都特别困难。
