Holdenrieder Stefan, Molina Rafael, Gion Massimo, Gressner Axel, Troalen Frédéric, Auge Jose Maria, Zancan Matelda, Wycislo Matthias, Stieber Petra
Institut für Klinische Chemie, Klinikum der Universität München, Munich, Germany.
Clin Chem Lab Med. 2008;46(5):588-99. doi: 10.1515/CCLM.2008.125.
Cancer antigen CA125 is known as a valuable marker for the management of ovarian cancer.
The analytical and clinical performance of the Access OV Monitor Immunoassay System (Beckman Coulter) was evaluated at five different European sites and compared with a reference system, defined as CA125 on the Elecsys System (Roche Diagnostics).
Total imprecision (% CV) of the OV Monitor ranged between 3.1% and 8.8%, and inter-laboratory reproducibility between 4.7% and 5.0%. Linearity upon dilution showed a mean recovery of 100% (SD + 8.1%). Endogenous interferents had no influence on OV Monitor levels (mean recoveries: hemoglobin 107%, bilirubin 103%, triglycerides 103%). There was no high-dose hook effect up to 27,193 kU/L. Clinical performance investigated in sera from 1811 individuals showed a good correlation between the Access OV Monitor and Elecsys CA125 (R = 0.982, slope = 0.921, intercept = +1.951). OV Monitor serum levels were low in healthy individuals (n = 267, median = 9.7 kU/L, 95th percentile = 30.8 kU/L), higher in individuals with various benign diseases (n = 549, medians = 10.9-16.4 kU/L, 95th percentiles = 44.2-355 kU/L) and even higher in individuals suffering from various cancers (n = 995, medians = 12.4-445 kU/L; 95th percentiles = 53.4-4664 kU/L). Optimal diagnostic accuracy for cancer detection against the relevant benign control group by the OV Monitor was found for ovarian cancer [area under the curve (AUC) 0.898]. Results for the reference CA125 assay were comparable (AUC 0.899).
The Access OV Monitor provides very good methodological characteristics and demonstrates an excellent analytical and clinical correlation with Elecsys CA125. The best diagnostic accuracy for the OV Monitor was found in ovarian cancer. Our results also suggest a clinical value of the OV Monitor in other cancers.
癌抗原CA125是卵巢癌管理中的一种重要标志物。
在欧洲五个不同地点对Access OV Monitor免疫分析系统（贝克曼库尔特公司）的分析性能和临床性能进行评估，并与参考系统进行比较，该参考系统定义为Elecsys系统（罗氏诊断公司）上的CA125。
OV Monitor的总不精密度（%CV）在3.1%至8.8%之间，实验室间重复性在4.7%至5.0%之间。稀释后的线性显示平均回收率为100%（标准差±8.1%）。内源性干扰物对OV Monitor水平无影响（平均回收率：血红蛋白107%，胆红素103%，甘油三酯103%）。在高达27,193 kU/L时无高剂量钩效应。对1811名个体血清的临床性能研究表明，Access OV Monitor与Elecsys CA125之间具有良好的相关性（R = 0.982，斜率 = 0.921，截距 = +1.951）。健康个体（n = 267，中位数 = 9.7 kU/L，第95百分位数 = 30.8 kU/L）的OV Monitor血清水平较低，患有各种良性疾病的个体（n = 549，中位数 = 10.9 - 16.4 kU/L，第95百分位数 = 44.2 - 355 kU/L）的水平较高，患有各种癌症的个体（n = 995，中位数 = 12.4 - 445 kU/L；第95百分位数 = 53.4 - 4664 kU/L）的水平更高。对于卵巢癌，OV Monitor针对相关良性对照组检测癌症的最佳诊断准确性为[曲线下面积（AUC）0.898]。参考CA125检测的结果相当（AUC 0.899）。
Access OV Monitor具有非常好的方法学特性，并且与Elecsys CA125具有出色的分析和临床相关性。OV Monitor在卵巢癌中具有最佳诊断准确性。我们的结果还表明OV Monitor在其他癌症中具有临床价值。
