IMMUNOASSAYS FOR GLYCOALBUMIN WITH MONOCLONAL ANTIBODY

这个第二阶段项目的目标是开发简单、具体和 可靠的免疫分析方法检测非酶糖化白蛋白 人体血浆。糖白蛋白的循环水平是一项指标。 过去3-4周内的环境血糖浓度。这个 检测使用EIA构建和使用的单抗 特别识别糖化白蛋白。第一阶段建立了 以单抗为基础测定糖白蛋白的可行性 微滴度酶联免疫吸附试验，优化了商品化的酶联免疫吸附试验条件 糖白蛋白水平与糖尿病其他指标的相关性评价 血糖与单抗反映的回溯期 抗体酶联免疫吸附试验测定糖蛋白。进一步的修改将产生 易于使用并快速给出定量结果的测试，使用两个 医生办公室中预期使用的格式类型。在 第一种类型，结果的量化是通过简单的 分光光度计，使用与抗体竞争的分析结构 固定在高亲和力结合试管上。第二种类型的 格式使用了一种“条带”格式，以实现颜色的视觉辨别 强度以确定糖化白蛋白的定义水平。一个完整的 方法将用于简化分析的运行方式，以 使分析既可靠又实用，以便在医生的 Office，以进一步验证修改后的分析，以选择最终固体 相矩阵和分析结构由稳定性和稳定性的组合最佳值 试剂的保质期与医生的安全性和简便性 办公室使用和完整的系统，能够吸引第三阶段的支持。

The objective of this Phase II project is to develop simple, specific and reliable immunoassays to measure non-enzymatically glycated albumin in human plasma. The circulating level of glycoalbumin is an index of the ambient blood glucose concentration over the preceding 3-4 weeks. The assays use EIA constructs and employ monoclonal antibodies that specifically recognize glycated albumin. Phase I established the feasibility of measuring glycoalbumin with a monoclonal antibody based microtiter ELISA, optimized the ELISA conditions for commercialization, and evaluated correlations between glycoalbumin levels and other parameters of glycemia and the retrospective period that is reflected by monoclonal antibody ELISA glycoalbumin measurement. Further modifications will yield tests that are easy to use and give rapid quantitative results, using two types of formats envisioned for use in the physician's office. In the first type, quantitation of results is achieved with a simple spectrophotometer, using a competitive assay construct with antibody immobilized onto high affinity binding test tubes. The second type of format uses a "strip" format to allow visual discrimination of color intensity to determine defined levels of glycated albumin. An integrated approach will be used to simplify the manner in which the assay is run, to make the assays both robust and practical for use in the physician's office, to further validate the modified assays, to select the final solid phase matrix and assay constructs from the combined optima of stability and shelf life of the reagents and the safety and simplicity for physician office use and to complete systems able to attract Phase III support.