用于检测CA15-3抗原的替代抗体：一项欧洲多中心研究，旨在评估UniCel Dxl 800免疫分析系统上的Access BR Monitor分析方法的分析性能和临床性能。

Alternative antibody for the detection of CA15-3 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access BR Monitor assay on the UniCel Dxl 800 Immunoassay System.

作者信息

Molina Rafael, Gion Massimo, Gressner Axel, Troalen Frédéric, Auge Jose Maria, Holdenrieder Stefan, Zancan Matelda, Wycislo Matthias, Stieber Petra

机构信息

Laboratory for Clinical Biochemistry and Molecular Genetics, Hospital Clinic, Barcelona, Spain.

出版信息

Clin Chem Lab Med. 2008;46(5):612-22. doi: 10.1515/CCLM.2008.133.

DOI:10.1515/CCLM.2008.133

PMID:18598203

Abstract

BACKGROUND

Cancer antigen CA15-3 antigen is known as a valuable marker for the management of breast cancer.

METHODS

The analytical and clinical performance of the Access BR Monitor Immunoassay System (Beckman Coulter) was evaluated at five different European sites and compared with a reference system, defined as CA15-3 on the Elecsys System (Roche Diagnostics).

RESULTS

Total imprecision (% CV) of the BR Monitor ranged between 5.5% and 11.7%, and inter-laboratory reproducibility between 3.4% and 5.1%. Linearity upon dilution showed a mean recovery of 98.5% (SD + 9.1%). Endogenous interferents had no influence on BR Monitor levels (mean recoveries: hemoglobin 112%, bilirubin 111%, triglycerides 108%). There was no high-dose hook effect up to 13,540 kU/L. Clinical performance investigated in sera from individuals showed a general correlation between the Access BR Monitor and Elecsys CA15-3 (R = 0.797), with a slope of 1.383. CA15-3 serum levels, as measured by the BR Monitor, were low in healthy individuals (n = 267, median = 11.9 kU/L, 95th percentile = 23.5 kU/L), higher in individuals with various benign diseases (n = 549, medians = 11.3-15.6 kU/L, 95th percentiles = 21.6-54.6 kU/L) and even higher in individuals suffering from various cancers (n = 995, medians = 11.2-22.8 kU/L, 95th percentiles = 30.0-429.7 kU/L). Best diagnostic accuracy for cancer detection against the relevant benign control group by the BR Monitor was found for locoregional and metastatic breast cancer, as well as for ovarian cancer [area under the curve (AUC) 0.619, 0.897 and 0.774]. Results for the reference CA15-3 assay were comparable (AUC 0.611, 0.887 and 0.818).

CONCLUSIONS

The Access BR Monitor provides accurate methodological characteristics and demonstrates an analytical and clinical correlation with Elecsys CA15-3. Best diagnostic accuracy for the BR Monitor was found in breast and ovarian cancer. Our results also suggest a clinical value of the BR Monitor in other cancers.

摘要

背景

癌抗原CA15 - 3抗原是乳腺癌管理中的一种重要标志物。

方法

在欧洲五个不同地点评估了Access BR 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，并与一个参考系统进行比较，该参考系统定义为Elecsys系统（罗氏诊断公司）上的CA15 - 3。

结果

BR Monitor的总不精密度（%CV）在5.5%至11.7%之间，实验室间的再现性在3.4%至5.1%之间。稀释后的线性显示平均回收率为98.5%（标准差±9.1%）。内源性干扰物对BR Monitor水平无影响（平均回收率：血红蛋白112%，胆红素111%，甘油三酯108%）。在高达13,540 kU/L时无高剂量钩效应。对个体血清进行的临床性能研究表明，Access BR Monitor与Elecsys CA15 - 3之间总体相关（R = 0.797），斜率为1.383。通过BR Monitor测量的CA15 - 3血清水平在健康个体中较低（n = 267，中位数 = 11.9 kU/L，第95百分位数 = 23.5 kU/L），在患有各种良性疾病的个体中较高（n = 549，中位数 = 11.3 - 15.6 kU/L，第95百分位数 = 21.6 - 54.6 kU/L），在患有各种癌症的个体中更高（n = 995，中位数 = 11.2 - 22.8 kU/L，第95百分位数 = 30.0 - 429.7 kU/L）。BR Monitor针对相关良性对照组检测癌症的最佳诊断准确性在局部和转移性乳腺癌以及卵巢癌中发现[曲线下面积（AUC）0.619、0.897和0.774]。参考CA15 - 3检测的结果具有可比性（AUC 0.611、0.887和0.818）。