Cioffi M, Fratta M, Gazzerro P, Di Finizio B, Tucci A, Molinari A M
Istituto di Patologia Generale e Oncologia, Seconda Università degli Studi di Napoli, Italy.
Tumori. 1997 Mar-Apr;83(2):594-8. doi: 10.1177/030089169708300223.
An immunoradiometric method of the second generation (IR-MA II) is widely used to determine CA125 serum levels. In this study we have evaluated the performance characteristics of a commercially available IRMA CA125 II (Byk-Gulden, Sangtec Diagnostica). The CA125 serum levels were determined in several groups of patients (healthy women, pregnant women, subjects affected by benign and malignant ovarian cancer, patients with liver diseases) with two IRMAs CA125 II (Byk-Gulden, Sangtec Diagnostica and Centocor, Diagnostic Division) and IRMA CA125 I (Byk-Gulden, Sangtec Diagnostica). Our results show a good analytic performance of IRMA CA125 II (Byk-Gulden, Sangtec Diagnostica), a good correlation between IRMAs CA125 II (Byk-Gulden, Sangtec Diagnostica and Centocor, Diagnostic Division), but an unacceptable correlation between IRMAs CA125 II (Byk-Gulden, Sangtec Diagnostica and Centocor, Diagnostic Division) and IRMA CA125 I. A statistically significant difference was observed comparing the values obtained with both IRMAs CA125 II and IRMA CA125 I in the groups of patients. In contrast no statistically significant difference was observed when we compared the values obtained with IRMA CA125 II (Byk-Gulden, Sangtec Diagnostica) and IRMA CA125 II (Centocor, Diagnostic Division). CA125 serum values obtained with the second-generation kits were different from those obtained with the first-generation one; consequently, it is important, especially in the follow-up of cancer patients, that CA125 serum values be obtained with kits of the same generation. Our data seem to suggest the use of second-generation kits to determine CA125 serum levels.
第二代免疫放射分析方法（IR-MA II）被广泛用于测定血清CA125水平。在本研究中，我们评估了市售IRMA CA125 II（拜耳古德恩公司，桑泰克诊断公司）的性能特征。使用两种IRMA CA125 II（拜耳古德恩公司，桑泰克诊断公司和先灵葆雅诊断部）以及IRMA CA125 I（拜耳古德恩公司，桑泰克诊断公司）测定了几组患者（健康女性、孕妇、患有良性和恶性卵巢癌的受试者、肝病患者）的血清CA125水平。我们的结果显示IRMA CA125 II（拜耳古德恩公司，桑泰克诊断公司）具有良好的分析性能，IRMA CA125 II（拜耳古德恩公司，桑泰克诊断公司和先灵葆雅诊断部）之间具有良好的相关性，但IRMA CA125 II（拜耳古德恩公司，桑泰克诊断公司和先灵葆雅诊断部）与IRMA CA125 I之间的相关性不可接受。在患者组中比较两种IRMA CA125 II和IRMA CA125 I获得的值时，观察到有统计学显著差异。相比之下，当我们比较IRMA CA125 II（拜耳古德恩公司，桑泰克诊断公司）和IRMA CA125 II（先灵葆雅诊断部）获得的值时，未观察到统计学显著差异。第二代试剂盒获得的血清CA125值与第一代试剂盒获得的值不同；因此，特别是在癌症患者的随访中，使用同一代试剂盒获得血清CA125值很重要。我们的数据似乎表明应使用第二代试剂盒来测定血清CA125水平。
