Martin M, Blockx P
Department of Nuclear Medicine, Antwerp University Hospital, Edegem, Belgium.
Anticancer Res. 1997 Jul-Aug;17(4B):3171-5.
The monoclonal antibody, OC125 (Centocor, Inc, Malvern, Pa) was the basis for the first generation, one step immunoradiometric assays (IRMA) to detect the CA 125 glycoprotein. Recently, two step IRMA's were developed, the CA 125 II generation assays. In these new assays the CA 125 capture antibody is the M11 monoclonal antibody coated on a solid phase and the OC125 monoclonal antibody is used as the tracer. We compared analytically and clinically one first generation radioassay, and three second generation assays (two radioassays and one ELISA). The ELISA method showed the best within-assay precision and the best curve fitting characteristics. In the clinical comparison, none of the correlations between the first and the second generation methods really satisfied, however the cut off level of 35 U/ml was confirmed. The four CA 125 assays do not yield equal results. As a consequence, the evolution of CA 125 serum concentration during disease monitoring is not reliable when different determination methods are used consecutively.
单克隆抗体OC125（Centocor公司，宾夕法尼亚州马尔文）是第一代一步免疫放射测定法（IRMA）检测CA 125糖蛋白的基础。最近，两步IRMA被开发出来，即CA 125第二代测定法。在这些新测定法中，CA 125捕获抗体是包被在固相上的M11单克隆抗体，而OC125单克隆抗体用作示踪剂。我们对一种第一代放射测定法和三种第二代测定法（两种放射测定法和一种酶联免疫吸附测定法）进行了分析和临床比较。酶联免疫吸附测定法显示出最佳的批内精密度和最佳的曲线拟合特性。在临床比较中，第一代和第二代方法之间的相关性均未真正令人满意，不过35 U/ml的临界值得到了确认。这四种CA 125测定法的结果并不相同。因此，当连续使用不同的测定方法时，疾病监测期间CA 125血清浓度的变化情况并不可靠。
