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

快速自动诊断f的试点实用性和前瞻性性能研究

• 批准号: 8750823
• 负责人: KRISTEN Jennifer KANACK
• 金额: $ 9.3万
• 依托单位: BIOFIRE DEFENSE, LLC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8750823
• 关键词: Adult; Aliquot; Antimicrobial Resistance; Award; Bacteria; Biological Assay; Blinded; Blood; Cerebrospinal Fluid; Cessation of life; Child; Clinical; Clinical Research; Clinical Sensitivity; Code; Cognitive; Communities; Complex; Data; Data Analyses; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic tests; Disease; Disease Outbreaks; Encephalitis; Epidemiology; Evaluation; Future; Genes; Goals; Gold; Health Care Costs; Hospitalization; Hour; Immune; Impaired cognition; In Vitro; Individual; Infection; Inflammatory; Laboratories; Lead; Left; Life; Marketing; Meningitis; Methods; Molecular; Nature; Neisseria meningitidis; Nested PCR; Neuraxis; Nucleic Acids; Organism; Outcome; Parasites; Patient Care; Patients; Performance; Population Surveillance; Public Health; Residual state; Reverse Transcription; Sensitivity and Specificity; Signs and Symptoms; Site; Specimen; Swab; System; Testing; Time; Training; United States National Institutes of Health; Virus; Work; Yeasts; age group; antimicrobial; base; clinical practice; design; hospital laboratories; improved; innovation; instrument; internal control; nucleic acid purification; outcome forecast; pathogen; patient population; prospective; public health relevance; research clinical testing; respiratory; user-friendly; viral detection

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.

描述(申请人提供)：脑膜炎和脑炎是中枢神经系统的炎症性疾病，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。根据涉及的病原体，脑膜炎和脑炎可能很快导致死亡或导致终身身体或认知挑战。这些病原体引起的体征和症状往往彼此非常相似，因此很难快速确定责任人和适当的治疗方法。目前用于从脑脊液(CSF)中识别病原体的微生物学方法通常速度慢且费力，从而使患者得不到诊断、可能得不到治疗或治疗不充分，并有可能将感染传播长达数天。BioFire诊断公司开发了薄膜阵列脑膜炎/脑炎(ME)面板，这是一种创新的分子诊断设备，可以同时快速从疑似脑膜炎和/或脑炎的患者的脑脊液中识别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仪器协同工作，执行检测和鉴定病原体(从核酸提取)所需的所有步骤 用于多重套式聚合酶链式反应和数据分析)。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，并在大约一个小时内返回清晰明确的结果。该项目的目标是在医院实验室环境中对FilmArray ME面板进行早期评估，以评估其性能及其作为脑膜炎/脑炎诊断测试的实用性。FilmArray ME专家组的早期评估将包括测试新鲜的、预期收集的、未确认的儿童和成人脑脊液样本，这些样本被送往医院实验室进行病原体测试。第一项任务将是通过与标准的实验室参考方法(如细菌和酵母培养以及病毒的聚合酶链式反应)进行比较，评估FilmArray ME结果的敏感性和特异性。第二项任务是分析不同因素的数据，如患者的年龄组、免疫状态、最终诊断和住院状态，以确定该设备总体上和特定患者组的实用性。这些数据将有助于确定FilmArray ME面板是否经过适当设计以满足脑膜炎/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)测试的监管许可之前，是否可以进行任何更改以改进该设备。