NOVEL ANTIGENS FOR THE SERODIAGNOSIS OF HUMAN BABESIOSIS

对扁虱传播感染的越来越多的监测表明，许多感染莱姆病的人与微小巴贝斯虫(人巴贝斯病的病原体)和埃利希菌混合感染，这两种病毒对免疫功能低下的人都有潜在的致命性，并已被证明影响输血。由于微小芽孢杆菌感染(类似疟疾的红细胞内寄生虫)的治疗与莱姆病有很大的不同，因此需要准确的血清学测试来区分这两种感染。拟议的研究将使使用B.microti重组体的ELISA和免疫印迹测试得以开发，这将补充目前可用的莱姆病测试，并最终促进对献血者的测试。这类检测的发展提高了我们鉴别诊断壁虱传播疾病的能力，并促进了适当治疗的实施。Corixa在鉴定免疫优势重组抗原方面已经取得了进展。这一点，再加上与扁虱传播疾病领域的主要研究人员的合作，血库和领先的莱姆病检测参考实验室以及获得其广泛的血清库，应该能够实现这项提议的目标和目的。拟议的商业应用拟议的研究将导致血库和参考实验室中使用的诊断测试的商业化。这种检测将在存在莱姆病和人类粒细胞性埃立克体病等其他扁虱传播感染的情况下，改进巴贝斯虫病的鉴别诊断。这种检测的估计市场应该与莱姆病检测在美国和世界各地的市场相似。目前对这一市场的估计为3000万至5000万美元/年，但如果血库检测被强制要求，甚至在区域基础上，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.