MONOCLONAL ANTIBODY IMMUNOASSAYS FOR GLYCOHEMOGLOBIN

描述：（改编自申请人摘要） 二期项目是开发简单、特异、可靠的免疫检测方法 测量非酶糖化血红蛋白的量 （人体血液中的糖化血红蛋白）。 循环中的糖化血红蛋白水平 是在之前的2-3个周期中的环境葡萄糖浓度的指数 个月 该测定使用ELISA构建体并采用单克隆抗体 能特异性识别糖化血红蛋白 第一阶段建立了 建立高度特异性单克隆抗体的可行性 以及将这些抗体应用于固相比色法中 用于定量人血液中糖化血红蛋白的ELISA。 进一步 修改将使测试易于使用，并提供快速 定量结果。 将制定两种格式， 验证. 第一类是对传统ELISA体系的改进 将提供实验室测试，可以定量与ELISA阅读器。 第二种格式，设想用于医生办公室，将 允许颜色强度的视觉辨别，以确定定义的水平 或者可以与新型电子阅读器装置一起使用， 给出绝对值。 电子阅读器设备正在开发中 独立工作，并组装了一个工作原型。 集成 方法将用于简化进行测定的方式， 使其在实验室中实用，在医生办公室中坚固耐用 使用，以进一步验证修改的测定，以选择最终固体 相位矩阵和来自以下组合最优值的测定构建体： 试剂的稳定性和保质期以及 技术人员和/或医生办公室使用。

DESCRIPTION: (Adapted from the applicants abstract) The objective of this Phase II project is to develop simple, specific and reliable immunoassays to measure the amount of non-enzymatically glycated hemoglobin (glycohemoglobin in human blood). The circulating level of glycohemoglobin is an index of the ambient glucose concentration over the preceding 2-3 months. The assays use an ELISA construct and employ monoclonal antibodies that specifically recognize glycated hemoglobin. Phase I established the feasibility of creating highly specific monoclonal antibodies to glycated hemoglobin and of applying these antibodies in solid phase colorimetric ELISAs for quantitation of glycohemoglobin in human blood. Further modifications will give tests that are easy to use, and give rapid quantitative results. Two types of formats will be developed and validated. In the first type, modification of conventional ELISA system will provide laboratory tests that can be quantitated with an ELISA reader. The second type of format, envisioned for use in the physician office, will allow visual discrimination of color intensity to determine defined levels of glycohemoglobin, or can be used with a novel electronic reader device to give absolute values. The electronic reader device is being developed independently and a working prototype has been assembled. An integrated approach will be used to simplify the manner in which the assays are run, to make them practical for laboratory use and robust for physician office use, to further validate the modified assays, to select the final solid phase matrices and the assay constructs from the combined optima of stability and shelf life of the reagents and the safety and simplicity for technician and/or physician office use.