NOVEL ANTIGENS FOR THE SERODIAGNOSIS OF HUMAN BABESIOSIS

对蜱传感染的监测增加表明，许多感染莱姆病的个体同时感染了小巴氏杆菌（人类巴贝斯虫病的病原体）和埃里希体，这两种病原体在免疫功能低下的个体中都可能致命，并已被证明会影响输血。自从治疗B. Microti感染（疟疾样红细胞内寄生虫）与莱姆病有很大不同，需要准确的血清学检测来区分这两种感染。 拟议的研究将能够开发使用B的ELISA和免疫印迹试验。Microti重组体的组合，将补充目前可用的莱姆病测试，并最终促进献血者的测试。 这种测试的发展提高了我们鉴别诊断蜱传疾病的能力，并促进了适当治疗的管理。 Corixa在鉴定免疫显性重组抗原方面已经取得了进展。 这一点，再加上与蜱传疾病领域的主要研究人员合作，血库和莱姆病检测的领先参考实验室以及获得其广泛的血清库，应能实现本提案的目标。拟议的商业应用拟议的研究将导致用于血库和参考实验室的诊断测试的商业化。 这些测试将提供在存在其他蜱传播的感染（例如莱姆病和人粒细胞埃里希体病）的情况下对巴贝斯虫病的改进的鉴别诊断。 这种测试的估计市场应该与美国和世界范围内的莱姆病测试相似。 目前对这个市场的估计是3000万至5000万美元/年，但如果血库检测甚至在区域基础上得到授权，这个数字可能会更高。

Increase surveillance of tick-borne infections has shown that many individuals infected with Lyme disease have co-infections with Babesia microti (agent of human babesiosis) and Ehrlichia, both of which are potentially fatal in immunocompromised individuals and have been shown to impact blood transfusions. Since the treatment of B. microti infections (malaria-like intraerythrocytic parasite) is vastly different that Lyme disease there is a need for an accurate serology test to differentiate the two infections. The proposed studies will enable the development of an ELISA and Immunoblot test using B. microti recombinants in combination that will supplement the currently available Lyme disease test and eventually facilitate testing of blood donors. Development of such tests improves our ability to differentially diagnose tick-borne diseases and facilitates administration of the appropriate treatment. Advances have already been achieved at Corixa in identifying immunodominant recombinant antigens. This, in combination with collaborations with key investigators in the area of tick-borne diseases, blood banking and a leading reference laboratory for Lyme disease testing and access to their extensive serum bank should enable the goals and objectives of this proposal to be achieved. PROPOSED COMMERCIAL APPLICATION The proposed studies will lead to commercialization of diagnostic tests for use in the blood bank and reference laboratory. Such tests would provide for improved differential diagnosis of babesiosis in the presence of other tick-borne infections e.g. Lyme disease and Human Granulocytic Ehrlichiosis. The estimated market for such a test should be similar to that for Lyme disease testing both in the U.S. and worldwide. Current estimates for this market are 30-50 million dollars/year but could be greater if blood bank testing is mandated even on a regional basis.