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    • 1. 发明授权
    • Immunoassay element containing a pulverized water-insoluble
polysaccharide and process for immunoassay
    • 含有粉碎水不溶性多糖的免疫测定元件和免疫测定方法
    • US5547848A
    • 1996-08-20
    • US393240
    • 1995-02-23
    • Hiroshi ShinokiToshikage HiraokaMasashi Ogawa
    • Hiroshi ShinokiToshikage HiraokaMasashi Ogawa
    • G01N33/542G01N33/543G01N33/558G01N33/535G01N33/548
    • G01N33/54386G01N33/558
    • An immunoassay element for quantitatively analyzing a ligand by determining the change in enzymatic activity. When the ligand is a low molecular weight antigen, competitive reactions between the ligand, enzyme-labelled antibody and conjugate of the antigen and high molecular weight compound are utilized. When the ligand is a macromolecular antigen, a reaction between the ligand and an enzyme-labelled antibody is utilized directly. The immunoassay element comprises a substrate layer containing a non-diffusible substrate which forms a diffusible material in the presence of the enzyme, and a reagent layer for detecting the thus formed diffusible material. The non-diffusible substrate is composed of a pulverized insoluble polysaccharide. The reagent layer may further contain a fragmenting enzyme for further fragmenting the non-diffusible material. Also provided are processes for quantitatively analyzing both of low molecular weight and macromolecular antigens contained in any samples by the use of the immunoassay elements of the invention.
    • 用于通过确定酶活性的变化定量分析配体的免疫测定元件。 当配体是低分子量抗原时,配体,酶标记抗体与抗原结合物和高分子量化合物之间的竞争性反应被利用。 当配体是大分子抗原时,直接使用配体和酶标记的抗体之间的反应。 免疫测定元件包括含有在酶存在下形成可扩散材料的不扩散基底的基底层和用于检测由此形成的可扩散材料的试剂层。 非扩散性基材由粉碎的不溶性多糖组成。 试剂层可以进一步包含用于进一步碎裂非扩散材料的碎裂酶。 还提供了通过使用本发明的免疫测定元件定量分析任何样品中所含的低分子量和大分子抗原的方法。
    • 3. 发明授权
    • Analysis element and method for analyzing glycated hemoglobin content
ratio
    • 分析元素及分析糖化血红蛋白含量的方法
    • US5882935A
    • 1999-03-16
    • US544133
    • 1995-10-17
    • Kikuo HiraiHiroshi ShinokiMasashi OgawaYoshihiko Makino
    • Kikuo HiraiHiroshi ShinokiMasashi OgawaYoshihiko Makino
    • G01N33/53G01N33/52G01N33/542G01N33/72H01L21/302H01L21/304H01L21/306H01L21/76
    • G01N33/723G01N33/721
    • An analysis element for analyzing both amounts of glycated hemoglobin and total hemoglobin in an aqueous liquid sample to determine glycated hemoglobin content ratio in the sample. The element comprises a substrate layer for receiving a reaction mixture after the completion of an immunological reaction between the glycated hemoglobin in the sample and an enzyme-labelled antibody against the glycated hemoglobin, and a reagent layer. The substrate layer contains a non-diffusible substrate which forms a diffusible material in the presence of the enzyme of the enzyme-labelled antibody, the activity of the enzyme being effected relative to the steric hindrance due to the immunological reaction. The reagent layer contains a reagent composition for reacting with the diffusible material to form a dye detectable colorimetrically in a wavelength range which is not effected by an absorption spectrum of the hemoglobin. The total hemoglobin retained in the substrate layer and the dye formed in the reagent layer are colorimetrically analyzed separately, and the glycated hemoglobin content ratio is calculated from respective values. An analysis method using this analysis element is also provided.
    • 分析元素,用于分析含水液体样品中糖化血红蛋白和总血红蛋白的量,以测定样品中糖化血红蛋白含量的比例。 该元件包括用于在样品中的糖化血红蛋白和糖化血红蛋白的酶标记抗体完成后的反应混合物和试剂层的基底层。 底物层含有在酶标记抗体的酶存在下形成可扩散材料的非扩散性底物,该酶的活性相对于由于免疫反应引起的空间位阻影响。 试剂层含有用于与可扩散材料反应的试剂组合物,以形成可在不受血红蛋白的吸收光谱影响的波长范围内比色测定的染料。 分别保留在基材层中的总血红蛋白和形成在试剂层中的染料,并根据各值计算糖化血红蛋白含量比。 还提供了使用该分析元素的分析方法。