A Simple Point of Care White Blood Cell Count Test

描述(由申请人提供)：提出了一种使用一次性试纸和手掌大小的读取器的手指棒状白细胞(WBC)计数分析方法。该方法将在非实验室环境中，如患者的家中，以分钟为单位估计WBC计数。用手工装配的样机获得的初步数据证明了该方法的可行性。一种用于测量WBC计数的简单护理点(POC)方法将为医疗保健提供者提供一种便携式手段来监控正在接受化疗的癌症患者。目前，还没有一种廉价而准确的方法可用。拟议的设备将通过允许医疗保健提供者在患者来接受治疗之前获得WBC计数来提高化疗日程安排的效率。这将反过来降低医疗成本。建议设备的PoC应用每年的全球潜在市场价值为1.6亿美元。在第二阶段，我们建议扩大设备的规模，开发手掌大小的阅读器，彻底测试检测系统，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 .