Hwang Hyundoo, Kim Jaesik, Choi Jaekyu, Kim Kil Hwan, Han Ho-Seong
Clin Lab. 2019 Aug 1;65(8). doi: 10.7754/Clin.Lab.2019.190130.
Tumor marker assays have played a crucial role for screening cancers and monitoring cancer patients, as they reflect the status and prognosis of patients. Alpha fetoprotein (AFP), prostate specific antigen (PSA), and carcinoembryonic antigen (CEA) are the most commonly used tumor marker proteins. The MARK BTM immunoassay system is a novel platform based on magnetic nanoparticles and electrochemical immunoassay.
The analytical performance of MARK BTM immunoassay system for determination of AFP, PSA, and CEA are evaluated. Comparisons of methods are also conducted by comparing the assay results of MARK BTM immunoassay system to that of cobas e 801 system.
The MARK BTM immunoassay system provides within-run, between-run, and between-day precisions for the three tumor markers, ranging from 1.13 - 7.46%. Data measured by the MARK BTM immunoassay system show high correlation with that of the cobas e 801 system, with a linear slope ranging from 0.966 to 1.042 and a correlation coefficient of r > 0.996 for the three markers.
These results show that the MARK BTM immunoassay system can be used for the quantitative measurements of AFP, PSA, and CEA in clinical practice.
肿瘤标志物检测在癌症筛查和癌症患者监测中发挥着关键作用，因为它们反映了患者的状况和预后。甲胎蛋白（AFP）、前列腺特异性抗原（PSA）和癌胚抗原（CEA）是最常用的肿瘤标志物蛋白。MARK BTM免疫分析系统是一种基于磁性纳米颗粒和电化学免疫分析的新型平台。
评估MARK BTM免疫分析系统测定AFP、PSA和CEA的分析性能。还通过将MARK BTM免疫分析系统的检测结果与cobas e 801系统的检测结果进行比较来进行方法比较。
MARK BTM免疫分析系统为三种肿瘤标志物提供了批内、批间和日间精密度，范围为1.13 - 7.46%。MARK BTM免疫分析系统测得的数据与cobas e 801系统的数据高度相关，三种标志物的线性斜率范围为0.966至1.042，相关系数r>0.996。
这些结果表明，MARK BTM免疫分析系统可用于临床实践中AFP、PSA和CEA的定量检测。
