DEVELOPMENT OF A WHOLE-BLOOD PLATELET AGGREGOMETER

描述(逐字摘自申请者摘要)：此第二阶段申请是 用于进一步开发、优化和临床测试血小板 功能测定称为光散射全血聚集仪(LSWBA)。 利用差示光散射检测的概念 未稀释的全血中的血小板聚集被证实是第一阶段的一部分 研究。此外，当LSWBA与现有的 基于实验室的聚合计，结果证明评估 LSWBA的血小板功能在性质上与现有设备相似。 目前世界上最令人窒息的血小板聚集仪的局限性 市场上的情况是，血液样本必须送到实验室进行检测 评估血小板功能。在这一点上评估血小板功能 护理可以极大地改善抗血小板治疗，为临床医生提供 有机会量身定做药物治疗方案，以满足个别患者的需要。LSWBA 解决了现有设备的所有后勤和概念限制 并准备成为一种真正的床边诊断工具，用于评估 血小板功能。这种设备的可用性将使医生能够 微调药物治疗，将血栓形成或出血的风险降至最低。这个 第二阶段的工作拟包括： 1)进一步优化和规范样品架，这是必不可少的 LSWBA的一部分，2)建立激动剂剂量-反应数据库 识别异常的血小板功能，3)测试护理点的效用 临床环境中的LSWBA。 建议的商业应用： 这项研究将导致一个原型的护理点诊断工具，以评估血小板功能。 这一工具将允许医生量身定做预防性和治疗性抗血小板药物方案 以一种以前不可能实现的方式。一种更有控制的抗血小板治疗不仅会 将不良反应的风险降至最低，但也将降低患者的发病率，并将导致 总体上改善了临床结果。目前的估计表明，市场潜力约为 每年1亿美元，用于护理点全血聚集仪的设备和用品。

DESCRIPTION (Verbatim From Applicant's Abstract):This phase II application is for further development, optimization, and clinical testing of a platelet function assay called the light scattering whole blood aggregometer (LSWBA). The concept of utilizing differential light scattering for the detection of platelet aggregates in whole, undiluted blood was proven as part of Phase I research. Further, when the LSWBA was compared with the existing laboratory-based aggregometers, the results documented that the assessment of platelet function with LSWBA was qualitatively similar to the existing devices. The most stifling limitation of the platelet aggregometers currently on the market is that blood samples have to be sent to the laboratory for the assessment of platelet function. Assessment of platelet function at the point of care may greatly improve antiplatelet therapy by providing clinicians the opportunity to tailor drug regimen to suit individual patient needs. The LSWBA addresses all the logistical and conceptual limitations of the existing devices and is poised to emerge as a true bedside diagnostic tool for the assessment of platelet function. The availability of such a device will enable physicians to fine-tune drug therapy and to minimize the risk of thrombosis or bleeding. The Phase II work is proposed to: 1) further optimize and standardize the sample holder which is an essential part of the LSWBA, 2) establish a databank of agonist dose-responses to later identify abnormal platelet function and, 3) test the point-of care utility of the LSWBA in the clinical environment. PROPOSED COMMERCIAL APPLICATION: This research will lead to a prototype point-of-care diagnostic tool to assess platelet function. This tool will permit physicians to tailor prophylactic and therapeutic antiplatelet drug regimen in a manner that was not possible before. A more controlled antiplatelet therapy will not only minimize the risk of adverse effects but will also reduce patient morbidity and will result in an overall improved clinical outcome. Current estimates suggest a market potential of approximately $100 million/year for equipment and supplies for a point-of-care whole blood aggregometer.