A Simple Point of Care White Blood Cell Count Test

描述（由申请方提供）：拟定使用一次性试纸和手掌大小的读数器开发手指针刺白色血细胞（WBC）计数测定方法。该方法将在非实验室环境（如患者家中）中以分钟为单位估计WBC计数。手动组装的原型获得的初步数据已经证明了所提出的方法的可行性。一个简单的即时（POC）的方法来测量白细胞计数将给医疗保健提供者一个便携式的手段来监测他们的癌症患者接受化疗。目前，还没有一种既便宜又准确的方法。所提出的设备将通过允许医疗保健提供者在患者接受治疗之前获得WBC计数来提高化疗调度效率。这反过来又会降低医疗成本。拟议设备的POC应用每年有1.6亿美元的潜在全球市场。在第二阶段，我们建议扩大设备，开发手掌大小的阅读器，彻底测试分析系统，并为第三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 .