Martin M J, Blockx P P
Department of Nuclear Medicine, Antwerp University Hospital, Belgium.
Int J Biol Markers. 1996 Jan-Mar;11(1):36-9. doi: 10.1177/172460089601100107.
The monoclonal antibody OC125 (Centocor, Inc, Malvern, PA) was the basis for the first generation of one-step immunoradiometric assays (IRMA), used to detect the glycoprotein CA 125. Recently two-step IRMAs were developed: the CA 125 second-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 tracer. We compared one first-generation radioassay and three second-generation assays (two radioassays and one ELISA) both analytically and clinically. 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-generation and second-generation methods were really satisfactory; however, the cutoff 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 concentrations 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分析（IRMA）的基础，用于检测糖蛋白CA 125。最近开发了两步IRMA：CA 125第二代分析方法。在这些新方法中，CA 125捕获抗体是包被在固相上的M11单克隆抗体，OC125单克隆抗体用作示踪剂。我们对一种第一代放射分析方法和三种第二代分析方法（两种放射分析方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达到真正令人满意的程度；然而，35 U/ml的临界值得到了确认。四种CA 125分析方法的结果并不相同。因此，当连续使用不同的测定方法时，疾病监测期间CA 125血清浓度的变化是不可靠的。
