Sundström B E, D'Amico Y, Brundell J
AB Sangtec Medical, Bromma, Sweden.
Int J Biol Markers. 1995 Jul-Sep;10(3):166-73. doi: 10.1177/172460089501000307.
A new immunoassay for TPA determination has been developed in which anticytokeratin monoclonal antibodies are used. A three-Mab combination with different anticytokeratin antibody specificities has been selected to mimic the complex pattern found for the polyclonal anti-TPA antibody. The accuracy of the assay is good, as judged from analytical-recovery experiments, analysis of quality-assessment samples and comparison with the polyclonal Prolifigen TPA IRMA. No significant interferences or cross-reactivities have been identified. The lower limit of detection of the assay (mean + 3 SD of the zero standard) is below 15 U/L and the imprecision in low, giving a working range of 15-4000 U/L. The improved handling of the assay, including a single incubation step of 2 hours with shaking at room temperature, results in a narrower normal distribution, thereby giving a better separation of normal and pathological samples.
已开发出一种用于检测组织多肽抗原（TPA）的新型免疫测定法，该方法使用抗细胞角蛋白单克隆抗体。已选择具有不同抗细胞角蛋白抗体特异性的三种单克隆抗体组合，以模拟多克隆抗TPA抗体所呈现的复杂模式。从分析回收率实验、质量评估样品分析以及与多克隆Prolifigen TPA免疫放射分析（IRMA）的比较来看，该测定法的准确性良好。未发现明显干扰或交叉反应。该测定法的检测下限（零标准品的平均值 + 3倍标准差）低于15 U/L，低水平时精密度良好，工作范围为15 - 4000 U/L。该测定法操作的改进，包括在室温下振荡孵育2小时的单一孵育步骤，使得正态分布变窄，从而能更好地区分正常和病理样品。
