A point of need clinical chemistry and hematology platform for improving accessibility to diagnostic testing

用于提高诊断测试可及性的临床化学和血液学平台需求点

• 批准号: 10757303
• 负责人: George Terrance Walker
• 金额: $ 29.76万
• 依托单位: GENERAL FLUIDICS, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10757303
• 关键词: Address; Biological Assay; Blood; Blood Platelets; Blood Tests; Blood capillaries; Blood specimen; Child; Childhood; Clinic; Clinical; Clinical Chemistry; Clinical Chemistry Tests; Collaborations; Collection; Complete Blood Count; Data Set; Development; Diagnostic tests; Edetic Acid; Elderly; Ensure; Evaluation; Evaluation Studies; Fingers; Future; General Hospitals; Goals; Guidelines; Health Personnel; Health care facility; Hematology; Heparin; Human Resources; Immunochemistry; Improve Access; Individual; Label; Laboratories; Leukocytes; Lithium; Managed Care; Massachusetts; Metabolic; Participant; Performance; Phase; Plasma; Primary Care; Primary Care Physician; Procedures; Process; Protocols documentation; Reproducibility; Resource-limited setting; Rural; Sampling; Specimen; System; Test Result; Testing; Time; Training; Tube; Validation; Venous; Vial device; Whole Blood; care outcomes; clinical development; clinical practice; commercialization; cost effective; health care settings; health management; healthy volunteer; improved; instrument; instrumentation; medical specialties; neonate; primary care setting; rapid test; research clinical testing; rural healthcare; success; urgent care; waiver

PROJECT SUMMARY Complete blood counts and a basic metabolic panel are the most ordered blood tests in nearly all clinical settings. These tests are predominantly conducted on expensive high-throughput instrumentation in centralized or well- equipped satellite laboratories. Currently, there is no cost-effective and efficient instrumentation that can conduct these tests at the point-of-need or in clinics that do not have access to centralized testing facilities. The development of clinical instruments that can increase access to testing and provide clinicians with earlier, actionable diagnostic tests results have significant potential to improve healthcare management in a variety of clinical settings including rural and low resource settings, pediatric and neonate testing, and urgent and primary care settings. Critically, in many of these settings, healthcare personnel can be limited. In these settings phlebotomists or other trained personnel required for blood draws and clinical testing are not typically present. Consequently, there is a need for diagnostic testing instrumentation that can improve the accessibility of testing in various healthcare settings. Critically, this instrumentation requires ease of use, including CLIA waiver status, while providing performance that is comparable to standard testing in centralized laboratory settings. However, there are no solutions available that meet this need. To address this need, General Fluidics has developed the Axess System, which is a unique, rapid, cost-effective, and high-performance point-of-need solution that combines comprehensive clinical chemistry and hematology testing into a single modular platform delivering results in 15 to 20 minutes. The Axess system has been validated with venous whole blood for hematology and plasma derived from venous blood for clinical chemistry testing. In this proposal, the Axess system will be validated using fingerstick (i.e., capillary blood), where performance equivalence with venous blood would support use of the Axess systems in clinical settings where phlebotomists are not present. This would support further optimization and commercialization of the Axess system with a FDA CLIA waiver, which would deliver the first comprehensive instrument with central laboratory performance that could be used at the point-of-need. General Fluidics has previously validated a basic metabolic panel and a complete blood count through clinical performance evaluation studies at Massachusetts General Hospital and in-house evaluations. The goal of this Phase I project will be to demonstrate equivalence for hematology and clinical chemistry testing that is performed on the Axess System with de-identified matched capillary and venous blood specimens.

项目摘要 在几乎所有临床环境中，完全血液计数和基本代谢面板是有序的血液检查。 这些测试主要是在集中或良好的昂贵的高通量仪器上进行的 设备齐全的卫星实验室。目前，没有可以进行成本效益和高效的仪器 这些测试在需要的地方或无法使用集中测试设施的诊所中进行。这 开发临床工具，可以增加对测试的机会并为临床医生提供早期的临床医生 可行的诊断测试结果具有改善各种医疗保健管理的巨大潜力 临床环境，包括农村和低资源环境，儿科和新生儿测试以及紧急和主要的主要环境 护理设置。至关重要的是，在许多情况下，医疗保健人员可能会受到限制。在这些设置中 通常不存在抽血和临床测试所需的静脉混血症患者或其他受过训练的人员。 因此，需要诊断测试仪器，以提高测试的可访问性 在各种医疗机构中。至关重要的是，该仪器需要易于使用，包括Clia豁免状态， 同时提供与集中实验室环境中标准测试相媲美的性能。然而， 没有可用的解决方案可以满足这一需求。为了满足这一需求，通用流体已经开发了 Axess系统，它是一种独特，快速，成本效益和高性能的解决方案 将综合的临床化学和血液学测试结合到一个单个模块化平台中 导致15至20分钟。斧头系统已用静脉全血进行血液学和 血浆源自用于临床化学测试的静脉血。在此提案中，斧头系统将是 使用指尖（即毛细血管血）进行了验证，其中表现与静脉血相当 支持在不存在静脉混蛋的临床环境中使用Axess系统。这将支持 使用FDA CLIA豁免对Axess系统的进一步优化和商业化，这将提供 可以在需要时使用的首个具有中央实验室性能的综合仪器。 通用流体先前已经通过临床验证了基本的代谢面板和完整的血液计数 马萨诸塞州综合医院和内部评估的绩效评估研究。目标的目标 第一阶段项目将证明进行血液学和临床化学测试的等效性 在带有识别的匹配毛细血管和静脉血液标本的轴心系统上。