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，中枢神经系统的炎症性疾病，是严重的公共卫生问题。这些病症可能由大量病原体引起，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身的身体或认知挑战。由这些病原体引起的体征和症状通常彼此非常相似，因此难以快速确定负责的代理和适当的治疗。目前用于从脑脊液（CSF）中鉴定病原体的微生物学方法通常缓慢而费力，因此使患者无法诊断，可能未经治疗或治疗不当，并可能传播感染长达数天。BioFire Diagnostics，Inc.开发了脑炎脑膜炎多重病原体核酸联检试剂盒，这是一种创新的分子诊断设备，可同时快速鉴定疑似脑膜炎和/或脑炎患者脑脊液中的16种常见病原体（细菌、病毒和酵母菌）。脑炎脑膜炎多重病原体核酸联检试剂盒（脑炎脑膜炎多重病原体核酸联检试剂盒）由一个精心设计的“实验室测试条”组成，该测试条与脑炎脑膜炎多重病原体核酸联检试剂盒（脑炎脑膜炎多重病原体核酸联检试剂盒）一起执行病原体检测和鉴定所需的所有步骤（从核酸提取 多重巢式PCR和数据分析）。该测试可以在几分钟内完成，只需要经过最低限度培训的操作员，并在大约一小时内返回清晰明确的结果。本项目的目标是在医院实验室环境中对脑炎脑膜炎多重病原体核酸联检试剂盒进行早期评估，以评价其作为脑膜炎/脑炎诊断检测试剂的性能和实用性。脑炎脑膜炎多重病原体核酸联检试剂盒的早期评估将包括检测来自提交给医院实验室进行病原体检测的儿童和成人的新鲜、前瞻性采集、去识别残留CSF标本。第一项任务是通过与标准实验室参考方法（如细菌和酵母菌培养以及病毒PCR）进行比较，评价FilmArray ME结果的灵敏度和特异性。第二项任务是分析不同因素的数据，例如患者年龄组、免疫状态、最终诊断和住院状态，以确定器械的总体效用和特定患者组的效用。这些数据将有助于确定脑炎脑膜炎多重病原体核酸联检试剂盒的设计是否适合满足脑膜炎/脑炎的未满足诊断需求，以及在进行更大规模的研究以获得体外诊断（IVD）检测的监管许可之前，是否可以进行任何变更以改进器械。

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.