Abstract

Background: 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. Methods: 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.
Results: 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.
Conclusions: These results show that the MARK BTM immunoassay system can be used for the quantitative measurements of AFP, PSA, and CEA in clinical practice.

DOI: 10.7754/Clin.Lab.2019.190130