SBIR Phase I: Novel Optical Platform for Patient Self Monitoring of Coagulation in Whole Blood

这个小企业创新研究第一阶段项目开发了一种用于口服抗凝治疗的家庭监测的新型光学系统，特别适用于患者有出血损伤危险的情况。目前销售的用于家庭检测的系统似乎在范围的高端存在精度和准确性问题，这可能导致显著的发病率和死亡率。在2006年至2008年期间，向FDA报告了近4000起与使用这一代手持测试设备有关的不良事件。在最严重的不良事件中，设备错误地报告了临床可接受范围内的数值，而患者表现出出血的临床症状，实验室检查显示患者抗凝血过度危险。在这个项目中提出的检测系统旨在监测rouleaux的聚集和分解，作为血块形成的指标。所提出的光学系统，如果成功，将特别调整到rouleaux的反聚集，因此，在超治疗范围内将更加准确和精确。美国有300万人长期接受口服抗凝治疗，他们将受益于家庭检测系统对剂量的更严格控制。自2003年医疗保险首次提供覆盖范围并于2008年扩大覆盖范围以来，进行家庭检测的人数有所增加，但目前进行家庭检测的人数仅占所有符合条件的人数的一小部分。随着家庭检测越来越流行，不良事件的数量也会随之增加。家庭测试系统必须在其整个报告范围内提供准确的结果，因为卫生保健专业人员没有机会根据患者的情况判断结果。S临床症状。如果使用得当，家庭检测系统对那些难以前往实验室或诊所进行定期检测的人，例如老年人、经济上处于不利地位的人以及地理上分散在农村地区的人，具有特别的价值。实现本研究提出的创新的家庭测试系统的开发和商业化有望提高口服抗凝治疗家庭监测的安全性。

This Small Business Innovation Research Phase I project develops a novel optical system for use in home monitoring of oral anticoagulation therapy, of particular benefit in situations where a patient is dangerously at risk of injury from a bleed. Current systems that are sold for use in home testing appear to have issues of precision and accuracy at the high end of the range, which may contribute to significant morbidity and mortality. In the period from 2006 to 2008 there were close to 4000 adverse events reported to the FDA associated with the use of this generation of handheld testing devices. In the most serious of these adverse events, the devices erroneously reported values within a clinically acceptable range, while the patient displayed clinical symptoms of bleeding, and laboratory tests showed that the patient was dangerously over anticoagulated. The detection system proposed in this project seeks to monitor the aggregation and dis-aggregation of rouleaux as an indicator of clot formation. The proposed optical system, if successful, is tuned particularly to the dis-aggregation of rouleaux and thus, will be more accurate and precise in the supratherapeutic range. There are three million people in the US who are on long term oral anticoagulant therapy and who would benefit from tighter control of their dosages enabled by the availability of home testing systems. The number of people who perform home testing has grown since Medicare first provided coverage in 2003 and then expanded coverage in 2008, yet currently the number of people who perform home testing represents only a small percentage of all persons eligible. As home testing becomes more popular, there can be expected a concomitant increase in the number of adverse events. Home test systems must give accurate results over their entire reporting range, as there is no opportunity for a health care professional to judge the result in the context of a patient?s clinical symptoms. When used properly, home test systems can be of particular value to those who find it difficult to visit a lab or clinic for regular testing, such as the elderly, the economically disadvantaged, and those who are geographically dispersed in rural areas. Development and commercialization of a home test system that implements the innovations proposed by this research is expected to increase the safety of home monitoring of oral anticoagulant therapy.