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

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

目的研究4种国产化学发光免疫分析法和Roche电化学发光免疫分析法在总前列腺特异性抗原（tPSA）检测上的可比性。方法收集45份临床血清样本，选取新产业生物医学工程股份有限公司、迈瑞生物医疗电子股份有限公司、安图生物工程股份有限公司、长光华医生物医药工程有限公司生产的4种国产化学发光免疫分析系统和Roche电化学发光免疫分析系统（分别简称新产业、迈瑞、安图、长光华医和Roche）共同测定其中的tPSA含量，评价5种检测方法的精密度，并将4种国产方法分别与Roche的方法进行比较。采用Wilcoxon符号秩检验和Spearman秩相关进行数据处理。结果5种方法精密度良好。Roche、新产业、迈瑞、安图、长光华医测得的tPSA含量分别为14.11（9.92, 36.09）、12.00（8.56, 27.23）、12.10（8.60, 29.87）、13.35（9.51, 32.85）、14.50（9.88, 40.06） μg/L。Roche所测结果与新产业、迈瑞、安图、长光华医测得的结果均有相关性（rs值：0.992、0.989、0.957、0.983，均P〈0.001）。将tPSA医学决定水平4.0 μg/L代入回归方程，得到Roche与新产业、迈瑞、安图、长光华医检测结果的偏差分别为－10.88%、－18.07%、0.23%、22.31%。结论不同国产化学发光免疫分析法与Roche电化学发光免疫分析法在tPSA检测结果的可比性上存在较大差异，这可为后续国产化学发光免疫分析系统检测结果的临床应用和标准化提供参考。

ObjectiveTo study the comparability of total prostate specific antigen （tPSA） measurement by four domestic chemiluminescence immunoassays （DCI） and electrochemiluminescence immunoassay （ECI）.MethodsA 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.ResultsThe 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.ConclusionThe 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.