Clinical Evaluation of Point of Care Raman Analysis for Diagnosis of Gout

床旁拉曼分析诊断痛风的临床评价

• 批准号: 9207158
• 负责人: Sivaram P Gogineni
• 金额: $ 22.32万
• 依托单位: SPECTRAL ENERGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9207158
• 关键词: Accident and Emergency department; Acute; Address; Admission activity; Affect; Agreement; Ambulatory Care; Amendment; American; Arthralgia; Arthritis; Aspirate substance; Bedside Testings; Calcium Pyrophosphate; Cardiovascular Diseases; Caring; Certification; Charge; Chronic; Classification; Clinic; Clinical; Clinical Research; Clinical assessments; Communication; Community Healthcare; Comorbidity; Credentialing; Development; Device Designs; Devices; Diagnosis; Diagnostic; Digestion; Disease; Economic Burden; Environment; Filtration; Future; Gout; Healthcare; Hospitals; Impaired health; Inpatients; Internal Medicine; Investigation; Joints; Knowledge; Laboratories; Laboratory Finding; Liquid substance; Medical; Metabolic syndrome; Methods; Microscope; Microscopic; Migraine; Modification; Molecular Profiling; Morbidity - disease rate; Optics; Orthopedics; Outcome; Outpatients; Pain; Parkinson Disease; Pathologist; Patients; Phase; Physicians; Polarization Microscopy; Policies; Population; Preparation; Procedures; Professional Organizations; Provider; Pseudogout; Quality of life; Reagent; Recurrence; Regulation; Reporting; Research; Research Personnel; Rheumatology; Sampling; Schedule; Sensitivity and Specificity; Services; Site; Small Business Innovation Research Grant; Spectrum Analysis; Spottings; Stress; Swelling; Symptoms; Synovial Fluid; Technology; Testing; Time; Training; Uncertainty; United States Agency for Healthcare Research and Quality; United States National Institutes of Health; Universities; Urate; Work; Writing; arthropathies; base; care seeking; college; cost; cost efficient; design; effective therapy; experience; follow-up; functional disability; improved; innovation; medical specialties; phase 1 study; phase 2 study; point of care; point-of-care diagnostics; polarized light; primary care setting; programs; prototype; research clinical testing; rheumatologist; spectral energy; standard of care; urgent care; user friendly software

Gout affects millions of people in the US and the economic burden due to the disease is comparable to other chronic conditions such as Parkinson's disease or migraine. Accurate identification of crystal identity is essential to pursue an appropriate form of treatment. Patients who have gout attacks seek care at hospitals, outpatient centers, urgent care or the ER with hot, swollen and painful joints; therefore, gout symptoms can be confused with other forms of arthritis. Conclusive diagnosis requires observation of synovial aspirates by polarized light microscopy (PLM) to confirm the presence of negatively or positively birefringent crystals. In practice, PLM analysis as a billable service requires a microscope equipped with compensated polarization optics and a Clinical Laboratory Improvement Amendments (CLIA) for the laboratory. Certification by pathologists or rheumatologists is done by professional organizations followed by credentialing and the hospital or lab that performs the analysis and subject to hospital policy about who may report PLM findings. For all intensive purposes, PLM is therefore only feasible in major healthcare centers and central laboratories in selected rheumatology practices. Therefore, clinicians on the front line may be unable to diagnose gout during their clinical encounter or they depend on presumptive diagnosis based on clinical symptoms that lack sensitivity and specificity. The new American College of Rheumatology gout classification criteria are an attempt to address this problem but truly, a facile and automated point of care testing for gout and pseudogout is needed in primary care settings to inform the diagnosis and treatment of these diseases. Point of care Raman device (POCR) is an existing prototype that is developed at Case Western Reserve University (CWRU) with past NIH R21 and R01 to identify MSU and CPPD crystals in synovial fluid. The method involves a simple and facile sample preparation to isolate crystals in a disposable cartridge that is then inserted in a compact, cost-efficient and automated device which identifies the crystal species based on fingerprint molecular spectroscopy. By design, the method should be able to be performed by the non-specialist with minimal training. POCR was evaluated using synovial fluid samples from symptomatic patients (N=174) and there was more than 90% agreement between the diagnoses of POCR and PLM conducted by a certified technician/pathologist. During a prior R01 (Akkus/Singer), clinical synovial sample analyses were performed by researchers. The current version of the device needs a moderate number of modifications and customization to ready it for use by clinicians. This Phase I SBIR will demonstrate that diagnosis of gout/pseudogout by POCR as executed by the non-specialist staff at point of service will agree with the diagnosis by PLM conducted by certified operators. During first aim the prototype developed in CWRU will be transferred to Spectral Energies LLC who will refine it to make a clinically executable prototype. The clinical prototype will be used and evaluated by clinical staff in the second aim. The diagnostic outcome of synovial fluid analysis on freshly collected samples by POCR in the hands of non-expert clinical staff will be compared to PLM analysis performed as standard of care. The Phase I study will provide us with a clinically applicable POCR and pave the way for a multi-site clinical assessment of the device in a follow up Phase II study that aims to demonstrate that POCR enables the diagnosis of gout in settings which are not equipped with PLM and CLIA certified laboratories and accredited operators.

痛风影响美国数百万的人，由于疾病而导致的经济负担与其他 诸如帕金森氏病或偏头痛等慢性病。准确识别晶体身份是 追求适当的治疗形式至关重要。痛风攻击的患者在医院寻求护理， 门诊中心，紧急护理或ER，炎热，肿胀和痛苦的关节；因此，痛风症状可能是 与其他形式的关节炎混淆。结论性的诊断需要观察滑膜攻击力 偏振光显微镜（PLM），以确认存在否定性或积极的双向晶体的存在。在 练习，PLM分析作为计费服务需要配备补偿极化的显微镜 用于实验室的光学和临床实验室改进修正案（CLIA）。认证 病理学家或风湿病学家由专业组织完成，然后是凭证和 进行分析并遵守医院政策的医院或实验室，以报告谁可能报告PLM调查结果。 因此，出于所有密集目的，PLM仅在主要的医疗保健中心和中央实验室中可行 在选定的风湿病实践中。因此，前线的临床医生可能无法诊断痛风 在临床相遇期间，或者根据缺乏临床症状的推定诊断 灵敏度和特异性。新的美国风湿病学院痛风分类标准是一个 尝试解决这个问题，但确实是对痛风和伪造的轻松而自动化的护理点测试 在初级保健环境中需要为这些疾病的诊断和治疗提供信息。护理拉曼 设备（POCR）是现有的原型 NIH R21和R01识别滑液中的MSU和CPPD晶体。该方法涉及一个简单的 样品准备以分离一次性墨盒中的晶体，然后将其插入紧凑，成本效益 和自动化装置，该装置根据指纹分子光谱识别晶体物种。经过 设计，该方法应能够由非专家进行最少的培训来执行。 Pocr是 使用有症状的患者的滑液样品进行评估（n = 174），超过90％ 由认证的技术员/病理学家进行的POCR诊断与PLM的诊断之间的一致。在 研究人员进行了先前的R01（Akkus/Singer），进行临床滑膜样品分析。电流 该设备的版本需要适量的修改和自定义，以准备它以供其使用 临床医生。这一阶段I SBIR将证明，POCR对痛风/伪造的诊断。 服务点的非专业人士将同意认证运营商进行的PLM诊断。 在第一个目标期间，CWRU开发的原型将被转移到Spectral Energies LLC中 它可以制作临床可执行的原型。临床原型将由临床人员使用和评估 第二个目标。 POCR在POCR中的新鲜收集样品的滑液分析的诊断结果 将非专家临床人员的手与作为护理标准进行的PLM分析进行比较。第一阶段 研究将为我们提供临床适用的POCR，并为多站点的临床评估铺平了道路 该设备在后续第二阶段研究中，旨在证明POCR可以诊断痛风 不配备PLM和CLIA认证的实验室和经认可的运营商的设置。