Portable automated device for rapid venous blood draws and point of care diagnostic analysis

 描述：诊断血液测试是美国最普遍的临床程序，每年进行超过10亿次测试。传统的血液检测方法包括进行静脉穿刺术，将样本运送到中央实验室，使用大型台式仪器分析样本，并将结果传递给临床医生。这是一个劳力密集、耗时和昂贵的过程，由于进行静脉穿刺术的困难或运输和分析样本所需的时间，经常会出现意想不到的延误。尤其是在医院急诊科(ED)，病人病情的快速变化需要立即做出反应，因此延误可能会危及生命。护理点(PoC)血液检测已经成为一种潜在地减少周转时间的方法，几种基于毛细血管抽血的设备已经实现了商业翻译。然而，与集中式检测相比，现有PoC检测的可用检测方法数量仍然有限，毛细血管血检测结果的准确性仍存在争议。通过静脉穿刺法抽取静脉血可以采集更大的血量，由于样本直接来自循环，因此产生更可靠的结果。然而，到目前为止，无论是作为独立的单元，还是与PoC测试平台结合使用，都没有全自动静脉置管设备可用。为了解决这些目前的局限性，我们团队正在开发一种便携式、自动化的设备，该设备可以执行静脉穿刺术，并在患者护理时在15到30分钟内提供定量诊断结果。这种便携式设备将通过对患者的静脉进行成像，自动将针插入选定的静脉，将血液吸入微流控芯片，并通过集成的光学成像平台进行机上血液分析。一台设备将能够支持大多数急诊科的吞吐量；这样，拟议的设备将成为一个一体化的便携式统计实验室，用于快速、自动化的紧急诊断。除了急救医学，该设备还可能在门诊和门诊设施、儿科和老年护理以及军事用途等领域产生强大影响。

 DESCRIPTION: Diagnostic blood testing is the most ubiquitous clinical procedure in the US, with over 1 billion tests performed annually. The traditional method of blood testing involves performing a venipuncture, transporting samples to a centralized lab, analyzing the samples using large benchtop instruments, and relaying the results to the clinician. This is a labor intensive, time consuming, and expensive process, and unexpected delays often arise due either to difficulties in performing the venipuncture or the time needed to transport and analyze the sample. Particularly in the hospital emergency department (ED), rapid changes in a patient's condition necessitate immediate response, and thus delays can be life threatening. Point of care (PoC) blood testing has emerged as a way to potentially reduce turnaround times, and several devices based on capillary blood draws have achieved commercial translation. However, in comparison to centralized testing, the quantity of available assays remains limited for existing PoC testing, and the accuracy of results obtained with capillary blood remains controversial. Venous blood draws via a venipuncture allows for the collection of a larger volume of blood, yielding more dependable results as the specimen comes directly from the circulation. However to date, no fully automated venous access devices are available, either as independent units, or coupled with POC testing platforms. To address these current limitations, our group is developing a portable, automated device that performs venipuncture and provides quantitative diagnostic results in 15 to 30 minutes at the point of patient care. The portable device will operate by imaging a patient's veins, autonomously introducing a needle into a selected vein, drawing blood into microfluidics chips, and performing on-board blood analysis via an integrated optical imaging platform. A single device will be able to support the throughput of most emergency departments; in this way, the proposed device would serve as an all-in-one portable STAT lab for rapid, automated emergency diagnostics. Outside of emergency medicine, the device could furthermore have strong impact in areas such as ambulatory and outpatient facilities, pediatric and geriatric care, as well as military use.