R&D- MEDICAL: BIOMEDICAL (BASIC RESEARCH)

该项目旨在开发一种酶免疫测定法（ELISA），用于筛选血液中的微小巴贝虫抗体。人类巴贝斯虫病是一种类似疟疾的疾病，由巴贝斯虫属的各种原生动物寄生虫感染红细胞引起。在美国报告的大多数人类感染是由微孢子虫引起的，它在美国东北部和中北部部分地区流行。微螺旋体感染通常无症状，但也可发展为严重疾病甚至死亡，特别是在免疫抑制、无脾或老年人中。

This project is aimed at the development of an enzyme immunoassay (ELISA) for screening blood for antibodies to Babesia microti. Human babesiosis is a malaria-like illness due to infection of red blood cells by various species of protozoan parasites belonging to the genus Babesia. Most human infections reported in the United States are caused by B. microti which is endemic in parts of the northeast and north central United States. B. microti infections are often asymptomatic but can also progress to severe illness and even death, particularly in individuals who are immunosuppressed, asplenic or elderly. Recent cases of fatal transfusion-transmitted babesiosis have led to the identification of this pathogen as a significant threat to the blood supply. Currently no commercial, validated and FDA approved test are available for B. microti, and donor questionnaires have proven ineffective in preventing introduction of Babesia into the blood supply. Tests now in use including immunofluorescence, microscopy and PCR are not easily adaptable to high throughput blood screening. This proposal describes the development and clinical trial of a microplate-based Babesia ELISA which can be performed on an automated, high throughput platform, with the sensitivity and specificity required for blood screening. The research plan has five specific aims: 1) completion of assay development, proceeding from an optimized R&D prototype to a manufacturable kit, 2) manufacturing scale up, 3) evaluation of assay performance on blood donors from Babesia endemic and non-endemic areas in an IND clinical trial, 4) follow-up study of seropositive donors to inform donor deferral and re-entry policy, and 5) preparation and submission of a BLA application to the FDA for licensure for blood screening use.