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 全血细胞计数和基本代谢小组是几乎所有临床环境中最有序的血液检查。 这些测试主要是在集中式或井式的昂贵的高通量仪器上进行的。 配备卫星实验室。目前，还没有成本效益和有效的仪器，可以进行 这些测试在需要时或在无法使用集中测试设施的诊所进行。的 开发临床仪器，可以增加测试的机会，并为临床医生提供更早， 可操作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，儿科和新生儿检测，以及紧急和初级 护理设置。至关重要的是，在许多这些设置中，医疗保健人员可能受到限制。在这些环境中 抽血和临床测试所需的抽血师或其他受过训练的人员通常不在场。 因此，需要能够改善测试的可及性的诊断测试仪器 in various各种healthcare健康settings设置.至关重要的是，这种仪器需要易于使用，包括CLIA豁免状态， 同时提供与集中实验室环境中的标准测试相当的性能。然而，在这方面， 没有满足这种需要的可用解决方案。为了满足这一需求，General Fluidics开发了 Axess系统是一种独特、快速、经济高效且高性能的需求点解决方案， 将全面的临床化学和血液学检测结合到一个模块化平台中， 15到20分钟内就能出结果Axess系统已通过静脉全血进行血液学验证， 来自静脉血的血浆用于临床化学测试。在这份提案中，Axess系统将 使用手指针刺来验证（即，毛细血管血），其中与静脉血的性能等效性将 支持在没有抽血医生的临床环境中使用Axess系统。这将支持 通过FDA CLIA豁免，进一步优化和商业化Axess系统， 第一台具有中心实验室性能的综合仪器，可在需要时使用。 General Fluidics先前已通过临床试验验证了基本代谢组和全血细胞计数 在马萨诸塞州总医院进行的性能评价研究和内部评价。这个目标 I期项目将证明进行的血液学和临床化学检测的等效性 在Axess系统上使用去识别匹配的毛细血管和静脉血液样本。