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.

痛风影响着美国数百万人，由于这种疾病造成的经济负担与其他疾病相当。 慢性疾病，如帕金森病或偏头痛。准确鉴定晶体的同一性， 必须采取适当的治疗方式。痛风发作的病人会去医院寻求治疗， 门诊中心，紧急护理或急诊室与热，肿胀和疼痛的关节;因此，痛风症状可以是 与其他形式的关节炎混淆。结论性诊断需要观察滑膜抽吸物， 偏振光显微镜（PLM）以确认负或正双折射晶体的存在。在 在实践中，PLM分析作为一项收费服务，需要配备一台具有补偿偏振功能的显微镜 光学和临床实验室改进修正案（CLIA）的实验室。认证 病理学家或风湿病学家是由专业组织完成的，随后是资格认证， 执行分析的医院或实验室，并遵守关于谁可以报告PLM结果的医院政策。 因此，对于所有密集型目的，PLM仅适用于大型医疗中心和中心实验室 在选定的流变学实践中。因此，一线的临床医生可能无法诊断痛风 在他们的临床遭遇，或他们依赖于推定诊断的基础上，临床症状，缺乏 敏感性和特异性。新的美国流变学学院痛风分类标准是一个 试图解决这个问题，但真正的，一个简单的和自动化的护理点测试痛风和假痛风 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。床旁拉曼 设备（POCR）是一种现有的原型，由凯斯西储大学（CWRU）开发， NIH R21和R 01鉴定滑液中的MSU和CPPD晶体。该方法涉及一个简单而容易的 样品制备，将晶体分离到一次性盒中，然后插入紧凑、经济高效的 以及基于指纹分子光谱学识别晶体种类的自动化装置。通过 设计，该方法应该能够由非专业人员进行最少的培训。POCR是 使用症状性患者（N=174）的滑液样本进行评价， POCR和PLM诊断之间的一致性由认证技术员/病理学家进行。期间 在R 01之前（阿库斯/Singer），研究人员进行了临床滑膜样本分析。当前 该设备的版本需要进行适度的修改和定制，以供 临床医生本I期SBIR将证明，通过POCR诊断痛风/假性痛风， 服务点的非专业人员将同意由认证操作员进行的PLM诊断。 在第一次瞄准期间，在CWRU开发的原型将被转移到Spectral Energies LLC，后者将改进 它可以制作一个临床上可执行的原型。临床原型将由临床工作人员使用和评估， 第二个目标。通过POCR对新鲜采集的样本进行滑液分析的诊断结果 将非专业临床工作人员的手与作为标准护理进行的PLM分析进行比较。I期 这项研究将为我们提供一个临床适用的POCR，并为多中心临床评估铺平道路。 该设备在后续的II期研究中，旨在证明POCR能够诊断痛风， 没有配备PLM和CLIA认证的实验室和经认证的操作员。