Development of a non-instrumental Prothrombin Time test

描述（由申请人提供）：一次性使用器械的开发 建议家庭使用非仪器化凝血酶原时间（PT）试验。一期 使用精密编织织物构建的流动通道的数据表明， 建议的测试设备的潜力。血流终点的形成是由于 凝血是可重复的，易于阅读，并显示出良好的相关性PT 和酒吧长度。一种简单而准确的一次性装置可能是一种 这是一个强大的工具，可以帮助患者在家监测PT。 本研究的具体目标是：1）完成 扩大原型装置，2）制定协议，以获得扩大规模和试点 生产设备，3）进行临床试验，以评估质量的 器械，以及4）提交FDA市场批准的数据。 拟议商业应用：不可用

DESCRIPTION (provided by applicant): Development of a disposable non-instrumented prothrombin time (PT) test for home use is proposed. Phase I data using flow channels built with precision woven fabric demonstrated the potential of the proposed test device. The blood flow endpoints formed due to clotting were repeatable, easy to read, and showed good correlation between PT and bar length. A simple and accurate disposable device is potentially a powerful tool to help patients monitor their PT at home. The specific objectives of this research are to: 1) finalize the design of the scale-up prototype device, 2) develop protocols to obtain scale-up and pilot production devices, 3) conduct clinical trials to evaluate the quality of the devices, and 4) submit data for FDA market approval. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE