MONOCLONAL ANTIBODY IMMUNOASSAYS FOR GLYCOHEMOGLOBIN

描述：(改编自申请者摘要)本次活动的目的 第二阶段项目是开发简单、特异和可靠的免疫分析方法。 测定非酶糖化血红蛋白的含量 (人体血液中的糖化血红蛋白)。糖化血红蛋白的循环水平 是之前2-3个月内环境葡萄糖浓度的指数 月份。这些检测使用了一种酶联免疫吸附试验构建和使用了单抗。 专门识别糖化血红蛋白的物质。第一阶段建立了 制备高特异性糖化单抗的可行性 血红蛋白及其在固相比色法中的应用 人血中糖化血红蛋白的ELISA定量方法。进一步 修改将提供易于使用的测试，并提供快速 量化结果。将开发两种格式和 已验证。第一种是对常规酶联免疫吸附试验系统的改进 将提供可用酶联免疫吸附测定仪定量的实验室检测。 第二种格式，设想在医生办公室使用，将 允许视觉辨别颜色强度以确定定义的级别 或可与新型电子阅读器一起使用，以 给出绝对值。电子阅读器设备正在开发中 已经独立完成，并组装了一个工作样机。一个完整的 将使用一种方法来简化分析运行的方式， 使它们适用于实验室使用，并适用于医生办公室 使用进一步验证修改后的分析，以选择最终固体 相矩阵和由组合最优的分析构造 试剂的稳定性和保质期，以及安全和简单 技术员和/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.