Evaluation of Four Tumor Markers (CEA, AFP, CA125 and CA19-9) on Sysmex HISCL- 5000 Immunoassay Analyzer

Abstract

Background: Although great effort in standardization has been instituted worldwide, discrepancies among results from different immunoassay analyzers are still reported. Hence the evaluation of new assays has been advised before their implementation in the laboratory. We evaluated the assay performance of the Sysmex HISCL-5000 automated analyzer in measuring four tumor markers i.e. CEA, AFP, CA 125 and CA 19-9 and method comparison with ARCHITECT i2000SR immunoassay analyzer. Method: The limit of detection, dilution linearity and imprecision performance of the four tumor marker assays were evaluated, and method comparison was done using 236 specimens collected from patients with respective cancers. Results: The results on the limit of detection, linearity and imprecision were highly acceptable. Good correlation was found between the two methods compared for all the tumor markers studied (R=0.96 for CA125; R=0.98 for CEA; R=0.99 for AFP and R=0.57 for CA19-9). Conclusion: In our study, HISCL-5000 immunoassay analyzer showed good analytical performance for the tested four tumor markers. Regardless of high correlations, Passing-Bablok regression indicated lower comparability between two immunoassays for CA 125 and CA19-9. Hence, it is of utmost importance for clinical laboratories to evaluate and do parallel testing before implementing any new assays.