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    • 7. 发明公开
    • Method to diagnose heart muscle damage
    • Verfahren zur Bestimm Hertz-Muskel-Schaden
    • EP2172776A1
    • 2010-04-07
    • EP09016084.7
    • 1997-12-15
    • Biosite Incorporated
    • Buechler, Kenneth F.McPherson, Paul H.
    • G01N33/68G01N33/545G01N33/543
    • G01N33/54366G01N33/6887G01N33/6893G01N2333/4712G01N2800/32G01N2800/324Y10S435/96Y10S435/962Y10S435/975Y10S436/808Y10S436/811Y10S436/824Y10S530/81Y10S530/811Y10S530/829Y10S530/83Y10S530/841
    • A method for the diagnosis of heart muscle damage comprising:
      using an immunoassay system to determine the amount of cardiac troponin I in a blood, plasma, or serum sample supspected of containing troponin from damaged heart muscle, said system comprising (a) formation of an antibody conjugate comprising an antibody coupled to a signal generating element, said antibody being capable of specifically binding to cardiac specific regions of the troponin I complexes and of unbound troponin I, (b) formation of a reaction mixture comprising said whole blood, plasma or serum sample incubated with said antibody conjugate, (c) application of said reaction mixture to a surface to which is bound at least one capture antibody capable of specifically binding to cardiac specific regions of troponin I, said capture antibody binding said antibody conjugate, whereby the immobilized conjugate produces a detectable signal upon formation of sandwich complexes, and (d) relating of the detectable signal to the amount of cardiac troponin I present in said sample, wherein said antibody is insensitive with respect to the free troponin I and cardiac troponin I complexed with troponin C and troponin T, i.e. yields an assay response for said free and complexed forms of cardiac troponin I that is the same within a factor of 2; and
      relating the amount of cardiac troponin I present in said sample to the occurrence or non-occurrence of heart muscle damage.
    • 一种用于诊断心脏肌肉损伤的方法,包括:使用免疫测定系统来测定血液,血浆或血清样品中含有肌钙蛋白的损伤心脏肌肉中肌钙蛋白I的量,所述系统包括(a)形成 抗体结合物,其包含与信号产生元件偶联的抗体,所述抗体能够特异性结合肌钙蛋白I复合物和未结合的肌钙蛋白I的心脏特异性区域,(b)形成包含所述全血,血浆或血清的反应混合物 样品与所述抗体缀合物孵育,(c)将所述反应混合物施用于结合有至少一种能够特异性结合肌钙蛋白I的心脏特异性区域的捕获抗体的表面,所述捕获抗体结合所述抗体缀合物,由此固定化 共轭物在形成夹心复合物时产生可检测的信号,和(d)将可检测信号与t相关 他存在于所述样品中的心肌肌钙蛋白I的量,其中所述抗体相对于与肌钙蛋白C和肌钙蛋白T复合的游离肌钙蛋白I和心肌肌钙蛋白I不敏感,即产生所述游离和复合形式的心肌肌钙蛋白I的测定响应 在2的范围内是相同的; 并将所述样品中存在的心肌肌钙蛋白I的量与心肌损伤的发生或不发生相关联。