Clinical Research Laboratory

临床实验室中心将为标本处理提供集中的质量控制服务， 管理、临床和病毒学实验室检测以及研究特定检测。的具体职能 核心是： I.处理临床研究（项目1、2）和登革热疫苗中采集的生物样本 研究对象（项目3）。核心实验室将维护和管理样本库存和样本 在合作实验室之间分配。 二.为项目1、2和3进行诊断性血清学和病毒学检测 a.应用酶免疫分析法（EIA）对急性登革病毒感染进行血清学诊断， 血凝抑制试验（HAI）。 B.用蚀斑减少中和法测定登革病毒型特异性中和抗体 比色法 C.登革病毒RT-PCR定性快速诊断急性登革病毒感染 D.用弓形虫从血浆样品中分离登革病毒。 三.量化病毒负荷。 a.使用荧光RT-PCR测定血浆/血清样品中的登革病毒RNA水平 从急性感染的受试者身上提取的样本 B.通过酶型特异性ELISA测定急性病受试者血浆/血清中的NSI抗原水平 项目1、2和3。 四.对项目1的新鲜血液样本进行流式细胞术分析，例如检测活化T细胞 细胞和登革热特异性T和B细胞在急性感染期间的功能特征。

Clinical Laboratory Core will provide centralized, quality controlled services for specimen processing and management, clinical and virologic laboratory testing, and study-specific tests. The specific functions of the Core are: I. To process biological samples collected in the clinical studies (Project 1, 2) and from dengue vaccine study subjects (Project 3). Core Laboratory will maintain and manage the sample inventory and sample distribution among collaborating laboratories. II. To perform diagnostic serologic and virologic assays for Projects 1, 2 and 3 a. serological diagnosis of acute dengue virus infections using enzyme immunoassay (EIA) and hemagglutination inhibition assay (HAI). b. measurement of dengue serotype-specific neutralizing antibodies by plaque reduction neutralization assay. c. rapid diagnosis of acute dengue virus infections by qualitative dengue virus RT PCR assay. d. isolation of dengue viruses from plasma samples using Toxorrhynchites splendens mosquitoes. III. To quantify the viral burden. a. measurement of dengue virus RNA levels using a fluorogenic RT PCR assay in plasma/serum samples from acutely infected subjects for Projects 1, 2, and 3. b. measurement of NSI antigen levels by serotype-specific ELISA in plasma/serum of acutely ill subjects for Project 1, 2, and 3. IV. To perform flow cytometry analyses on fresh blood samples for Projects 1 e.g. detection of activated T cells and functional characterization of dengue-specific T and B cells during an acute infection.