Pilot utility and prospective performance study of a rapid automated diagnostic f

描述（由申请人提供）：脑膜炎和脑炎是中枢神经系统的炎症，是严重的公共卫生问题。这些情况可能是由大量的病原体引起的，包括细菌、病毒、酵母和寄生虫。根据所涉及的病原体，脑膜炎和脑炎可迅速导致死亡或导致终生的身体或认知挑战。这些病原体引起的体征和症状往往彼此非常相似，因此很难迅速确定负责的病原体和适当的治疗。目前用于从脑脊液（CSF）中鉴定病原体的微生物学方法往往缓慢而费力，从而使患者得不到诊断，可能得不到治疗或治疗不充分，并可能使感染传播长达数天。BioFire Diagnostics, Inc.开发了FilmArray脑膜炎/脑炎（ME）面板，这是一种创新的分子诊断设备，可同时从疑似患有脑膜炎和/或脑炎的患者的脑脊液中快速识别16种常见病原体（细菌、病毒和酵母）。FilmArray ME面板由一个独特设计的“袋中实验室”组成，它与FilmArray仪器一起执行检测和鉴定病原体（从核酸提取）所需的所有步骤

DESCRIPTION (provided by applicant): Meningitis and encephalitis, inflammatory conditions of the central nervous system, are serious public health concerns. These conditions may be caused by a large number of pathogens, including bacteria, viruses, yeast, and parasites. Depending upon the pathogen involved, meningitis and encephalitis can quickly lead to death or result in life-long physical or cognitive challenges. The signs and symptoms caused by these pathogens are often very similar to one another, thus making it difficult to quickly determine the responsible agent and appropriate treatment. Current microbiological methods used to identify pathogens from cerebrospinal fluid (CSF) are often slow and laborious, thus leaving patients undiagnosed, possibly untreated or inadequately treated, and potentially spreading infection for up to several days. BioFire Diagnostics, Inc. has developed the FilmArray Meningitis/Encephalitis (ME) Panel, an innovative molecular diagnostic device for simultaneous rapid identification of 16 common pathogens (bacteria, viruses, and yeast) from CSF of patients suspected of having meningitis and/or encephalitis. The FilmArray ME Panel consists of a uniquely-designed "lab-in-a-pouch" that works together with the FilmArray Instrument to perform all steps necessary for detection and identification of the pathogens (from nucleic acid extraction to multiplex nested PCR and data analysis). The test can be set up in a matter of minutes, requiring only minimally trained operators, and returns clear unambiguous results in approximately one hour. The goal of this project is to perform an early assessment of the FilmArray ME Panel in the hospital laboratory setting to evaluate its performance and its utility as a diagnostic test for meningitis/encephalitis. The early assessment of the FilmArray ME Panel will involve testing fresh, prospectively-collected, de-identified residual CSF specimens from children and adults submitted to the hospital laboratory for pathogen testing. The first task will be to evaluate the sensitivity and specificity of the FilmArray ME results by comparison to standard laboratory reference methods, such as culture for bacteria and yeast, and PCR for viruses. The second task will be to analyze the data with regards to different factors, such as age group of the patients, immune status, final diagnosis, and hospitalization status, to determine the utility of the device overall and for specific groups of patients. Together these data will help to determine if the FilmArray ME Panel is appropriately designed to fill the unmet diagnostic needs for meningitis/encephalitis and if any changes can be made to improve the device before larger studies are performed for regulatory clearance as an in vitro diagnostic (IVD) test.