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    • 5. 发明授权
    • Hepatitis B testing reagent and method
    • 乙型肝炎检测试剂及方法
    • US4189464A
    • 1980-02-19
    • US903238
    • 1978-05-05
    • Baruch S. BlumbergIrving Millman
    • Baruch S. BlumbergIrving Millman
    • G01N33/576G01N33/16A61K43/00G21H5/02
    • G01N33/5764Y10S436/804Y10S436/809Y10S436/81Y10S436/82
    • A test reagent reagent for HB.sub.s A.sub.g is prepared by applying to a suitable substrate, such as a polystyrene bead, a first coat of purified HB.sub.s A.sub.g to an extent which will permit complete coverage by anti-HB.sub.s. After washing HB.sub.s A.sub.g coated substrate, serum containing anti-HB.sub.s, or an IgG fraction of serum containing anti-HB.sub.s, is applied as a second coat as a second coat in an amount which substantially completely occupies the reacting sites of the HB.sub.s A.sub.g on the outside of the substrate and leaves an excess of antibody reacting groups in a free state, and any unattached material is washed off.A test sample which is to be tested for HB.sub.s A.sub.g is then contacted with the reagent thus produced, permitting attachment of HB.sub.s A.sub.g if present, and washing is done.Then a source of anti-HB.sub.s, such as an IgG fraction containing anti-HB.sub.s, which has been radioactively labeled, is brought into contact with the reagent is brought into contact with the reagent, and any unattached material is washed off. The presence or absence of HB.sub.s A.sub.g in the test sample is determined sample is determined from the presence or absence of significant additional radiation coming from the reagent as compared with a control.This method and its double coated test reagent permits securing high sensitivity without any manufacture of "dissociated" anti-HB.sub.s separately from the process itself, for use at any stage of the process, which separate manufacture of "dissociated" anti-HB.sub.s is a difficult and expensive procedure which adds greatly to the expense of any radioimmunoassay which calls for it to be done.
    • 通过将合适的底物例如聚苯乙烯珠,第一层纯化的HBsAg涂覆到允许抗HBs完全覆盖的程度来制备用于HBsAgis的试剂试剂。 在洗涤HBsAg包被的底物之后,将含有抗-HBs的血清或含有抗HBs的血清的IgG部分作为第二涂层作为第二涂层施用,其量基本上完全占据HBsAg外部的HBsAg的反应位点 底物并离开过量的抗体反应基团,并且任何未附着的材料被洗去。 然后将待测试的HBsAg测试样品与所产生的试剂接触,如果存在HBsAg,则进行洗涤。 然后将与放射性标记的含有抗HBs的抗HBs的来源与试剂接触,与试剂接触,并将任何未附着的材料冲洗掉。 在测试样品中存在或不存在HBsAg时,与对照相比,测定样品是否存在或不存在来自试剂的显着额外辐射。 该方法及其双涂层测试试剂可以确保高灵敏度,而不会与工艺本身分开制造“解离”的抗HBs,以便在该过程的任何阶段使用,分离制造“分离的”抗HBs是一个困难的 和昂贵的程序,这大大增加了要求完成的任何放射免疫测定的费用。