Comparability of serum total prostate-specific antigen measurement by four domestic chemilumines-cence immunoassays and electrochemiluminescence immunoassay
10.3760/cma.j.issn.2095-2848.2018.11.008
- VernacularTitle:四种国产化学发光免疫分析法和电化学发光免疫分析法检测血清总前列腺特异性抗原的可比性
- Author:
Yancai WEI
1
;
Jialing WEI
;
Yan SHI
;
Kexue YE
;
Miaoli SONG
;
Gengchao ZHU
;
Chen YANG
Author Information
1. 215002,南京医科大学附属苏州医院核医学科
- Keywords:
Prostate-specific antigen;
Chemiluminescent measurements;
Immunoassay
- From:
Chinese Journal of Nuclear Medicine and Molecular Imaging
2018;38(11):745-748
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the comparability of total prostate specific antigen ( tPSA) meas-urement by four domestic chemiluminescence immunoassays ( DCI) and electrochemiluminescence immuno-assay ( 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 com-pared 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 coeffi-cients 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 4.0μg/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 pro-vides some references for clinical application and standardization of the DCI test results.
