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

项目总结 在几乎所有的临床环境中，完整的血细胞计数和基本代谢测试是最有序的血液测试。 这些测试主要是在集中或油井中昂贵的高通量仪器上进行的。 配备了卫星实验室。目前，还没有一种经济高效的仪器可以进行 这些检测是在需要时或在无法使用集中检测设施的诊所进行的。这个 临床仪器的开发可以增加检测的机会，并为临床医生提供更早的、 可操作的诊断测试结果具有显著的潜力来改善各种疾病的医疗保健管理 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初级 护理设置。关键的是，在许多这样的环境中，医护人员可能是有限的。在这些设置中 抽血和临床检测所需的抽血员或其他训练有素的人员通常不会出席。 因此，需要能够提高测试的可及性的诊断测试仪器 在各种医疗保健环境中。重要的是，该工具需要易用性，包括CLIA放弃状态， 同时提供可与集中式实验室环境中的标准测试相媲美的性能。然而， 目前还没有满足这一需求的解决方案。为了满足这一需求，General Fluidics开发了 AXESS系统，这是一种独特、快速、经济高效的高性能按需点解决方案， 将全面的临床化学和血液学检测整合到一个模块化平台中，提供 在15到20分钟内得到结果。Axess系统已经在静脉全血中进行了血液学和 从静脉血中提取的血浆用于临床化学测试。在这项提案中，Axess系统将是 使用指棒(即毛细血管血液)进行验证，其中与静脉血液的性能相当 支持在抽血员不在场的临床环境中使用Axess系统。这将支持 获得FDA CLIA豁免后，Axess系统进一步优化和商业化，这将提供 第一台具有中央实验室性能的综合仪器，可在需要时使用。 General Fluidics之前已经通过临床验证了基本代谢小组和完整的血细胞计数 马萨诸塞州综合医院的绩效评估研究和内部评估。这样做的目的是 第一阶段项目将证明所进行的血液学和临床化学测试的等效性。 在Axess系统上发现了匹配的毛细血管和静脉血样本。

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.