Birk B, Henne V, Hipp B, Meyer A
Roche Diagnostic Systems, Basel, Switzerland.
Anticancer Res. 1997 Jul-Aug;17(4B):2911-4.
Especially in patients with pancreatic carcinoma (1-5) (89%) the high molecular weight mucin CA 19-9 (MG 210 kD) shows a high specificity (98.5%) and sensitivity (up to 82%) (6-7). The mayor problem in the field of CA 19-9 diagnostics is the lack of satisfying comparability between CA 19-9 test kits: external proficiency studies (8) indicate a discrepancy between enzymatic and isotopic tests regarding their correlation. The Cobas Core CA 19-9 EIA II contributes to the standardisation of the CA 19-9 kits and allows the switching over from CA 19-9 IRMA's to EIA's. The test can be performed on the random access immunochemistry analyzer Cobas Core with a total assay time of 75 minutes by using 20 microliters of serum or plasma specimens. The analytical sensitivity was determined to be > 0.3 IU/ml. The 2 recalibrators cover a measuring range from 0 to 400 IU/ml. A high-dose-hook effect was not observed up to a concentration of 400,000 IU/ml. Interferences from the sample caused by heterophilic antibodies are reduced to a minimum. Precisions for intra-assay and inter-assay ranged below 5% and 6% respectively. In summary, the Cobas Core CA 19-9 II EIA exhibits a significant improvement regarding the correlation to CA 19-9 radioimmunometric methods (CIS, Centocor).
尤其是在胰腺癌患者中（1 - 5例）（89%），高分子量粘蛋白CA 19 - 9（分子量210 kD）显示出高特异性（98.5%）和高敏感性（高达82%）（6 - 7）。CA 19 - 9诊断领域的主要问题是CA 19 - 9检测试剂盒之间缺乏令人满意的可比性：外部能力验证研究（8）表明酶法和同位素法检测之间在相关性方面存在差异。Cobas Core CA 19 - 9 EIA II有助于CA 19 - 9试剂盒的标准化，并允许从CA 19 - 9免疫放射分析（IRMA）转换为酶免疫分析（EIA）。该检测可在随机存取免疫化学分析仪Cobas Core上进行，使用20微升血清或血浆标本，总检测时间为75分钟。分析灵敏度测定为> 0.3 IU/ml。两种校准品覆盖的测量范围为0至400 IU/ml。在浓度高达400,000 IU/ml时未观察到高剂量钩效应。由嗜异性抗体引起的样本干扰降至最低。批内精密度和批间精密度分别低于5%和6%。总之，Cobas Core CA 19 - 9 II EIA在与CA 19 - 9放射免疫测定方法（CIS，Centocor）的相关性方面有显著改进。
