Comparability of serum total prostate-specific antigen measurement by four domestic chemiluminescence immunoassays and electrochemiluminescence immunoassay

Abstract

Objective To study the comparability of total prostate specific antigen (tPSA) measurement by four domestic chemiluminescence immunoassays (DCI) and electrochemiluminescence immunoassay (ECI). Methods A total of 45 serum samples that requested tPSA tests were selected. Four DCIs (Snibe MAGLUMI 4000, Mindray CL-2000i, Autobio A2000, HYBIOME AE180) and ECI (Roche Cobas e601) were used to measure tPSA. The precisions of the methods were evaluated. The four DCIs were compared with Roche ECI respectively, and the comparability of the test results was analyzed. Wilcoxon signed rank test and Spearman correlation analysis were used to analyze the data. Results The precisions of five methods were good. The tPSA levels measured by Roche Cobas e601, Snibe MAGLUMI 4000, Mindray CL-2000i, Autobio A2000, and HYBIOME AE180 were 14.11(9.92, 36.09), 12.00(8.56, 27.23), 12.10(8.60, 29.87), 13.35(9.51, 32.85) and 14.50(9.88, 40.06) μg/L, respectively. The correlation coefficients of Roche with Snibe MAGLUMI 4000, Mindray CL-2000i, and Autobio A2000 were 0.992, 0.989, 0.957 and 0.983, respectively (all P<0.001). Assuming the tPSA medical decision point for regression equation was 4.0 μg/L, the proportional biases of Snibe MAGLUMI 4000, Mindray CL-2000i, Autobio A2000, and HYBIOME AE180 compared with Roche were -10.88%, -18.07%, 0.23% and 22.31%, respectively. Conclusion The comparability of tPSA test results is different between 4 DCIs and Roche ECI, which provides some references for clinical application and standardization of the DCI test results. Key words: Prostate-specific antigen; Chemiluminescent measurements; Immunoassay