A Simple Point of Care White Blood Cell Count Test

描述（由申请人提供）：建议开发一种使用一次性测试条和手掌大小的读取器的指尖白细胞（WBC）计数测定方法。该方法将在非实验室环境（例如患者家中）中在几分钟内估算出白细胞计数。手动组装原型获得的初步数据证明了该方法的可行性。用于测量白细胞计数的简单护理点 (POC) 方法将为医疗保健提供者提供一种监测正在接受化疗的癌症患者的便携式方法。目前，还没有廉价且准确的方法可用。拟议的设备将允许医疗保健提供者在患者接受治疗之前获得白细胞计数，从而提高化疗安排效率。这反过来又会降低健康成本。该设备的 POC 应用每年具有 1.6 亿美元的全球潜在市场。在第二阶段，我们建议扩大该设备的规模，开发手掌大小的阅读器，彻底测试测定系统，并为第二阶段的临床试验做准备。

DESCRIPTION (provided by applicant): Development of a finger-stick white blood cell (WBC) count assay method using a disposable test strip and a palm-size reader is proposed. The method will estimate the WBC count in minutes in a non-laboratory setting such as the patient's home. Preliminary data obtained with manually assembled prototypes have demonstrated the feasibility of the proposed method. A simple point-of-care (POC) method for measuring a WBC count will give healthcare providers a portable means of monitoring their cancer patients undergoing chemotherapy. Currently, there is no inexpensive and accurate method available. The proposed device will increase chemotherapy scheduling efficiency by allowing healthcare providers to obtain a WBC count before the patient comes in for therapy. This will in turn reduce health costs. POC applications for the proposed device have a potential worldwide market of $160 million annually. In Phase II, we propose to scale-up the device, develop a palm-size reader, thoroughly test the assay system, and prepare for a clinical trial in Phase IIl .