摘要
目的探讨罗氏cobas E602型全自动电化学发光免疫分析仪和深圳新产业Biolumi 8000型模块化化学发光免疫分析仪检测血清CA153的结果一致性。方法将2020年1月至2022年1月柳州市人民医院收治的恶性肿瘤患者89例,健康志愿者46例作为研究对象。运用罗氏cobas E602型全自动电化学发光免疫分析仪和深圳新产业Biolumi 8000型模块化化学发光免疫分析仪检测受试人员血清CA153水平,CA153<30 U/mL为低浓度,30~300 U/mL为中浓度,300~500 U/mL为高浓度,参照美国临床实验室标准化委员会(NCCLS)EP9-A2文件要求,对检测结果的一致性进行统计分析(包括绝对偏倚分析、相对偏倚分析、Pearson相关性分析和临床可接受评价)。结果两种检测方法的CA153检测结果差异无统计学意义(P>0.05)。CA153在95%一致性界限内占比均>95.00%,相对偏倚和绝对偏倚符合评价要求。两种检测系统检测结果的相关系数为0.989(P<0.01),呈高度正相关。低浓度、中浓度CA153的相对偏倚SE%均>12.5%。Bland-Altman分析显示,两种检测方法差值随着CA153浓度增高而增大,中、高浓度检测数值不具有一致性。结论罗氏cobas E602型全自动电化学发光免疫分析仪和深圳新产业Biolumi 8000型模块化化学发光免疫分析仪检测血清CA153的相关性良好,两者的检验效能一致,均能满足临床检测需求。当CA153在30~300 U/mL浓度范围内时,两个检测系统检测数值不具有可比性。
Objective To investigate the feasibility of the consistency of serum CA153 results between Roche cobas E602 automatic electrochemiluminescence immunoassay analyzer and Shenzhen New Industry Biolumi 8000 modular chemiluminescence immunoassay analyzer.Methods Eighty-nine patients with malignant tumors admitted to Liuzhou People's Hospital from January 2020 to January 2022 and 46 healthy volunteers in the same period were included.Serum CA153 levels of all subjects were detected by the above two analyzers,with CA153<30 U/mL as low concentration,30-300 U/mL as medium concentration,and 300-500 U/mL as high concentration.Statistical analysis(including absolute bias analysis,relative bias analysis,Pearson correlation analysis,clinical acceptability evaluation)was performed for the consistency of the detection results with reference to the requirements of the National Committee for Clinical Laboratory Standards(NCCLS)EP9-A2 document.Results There was no significant difference in the detection results of CA153 between the two analyzers(P>0.05).The percentage of CA153 within the 95%limits of agreement were greater than 95.00%,and the relative and absolute biases were in accordance with the evaluation requirements.The correlation coefficient between the serum CA153 results by the two detection systems was 0.989(P<0.01),showing a high positive correlation.The relative bias SE%was higher than 12.5%for both low and medium concentrations of CA153.Bland-Altman analysis showed that the difference of the serum CA153 results between the two detection systems increased with the increase of CA153 concentration,and the values of medium and high concentrations were not consistent.Conclusion Roche cobas E602 automatic electrochemiluminescence immunoassay analyzer and Shenzhen New Industry Biolumi 8000 modular chemiluminescence immunoassay analyzer are well correlated in detecting serum CA153,and are consistent in detection efficiency,which can meet the clinical detection needs.When CA153 is within the concentration range of 30-300 U/mL,the values of CA153 detected by the two detection systems are not comparable.
作者
刘纲毅
陈葭
谢妹珍
Liu Gangyi;Chen Jia;Xie Meizhen(Department of Laboratory Medicine,Liuzhou People's Hospital,Liuzhou 545006,China;Liuzhou Key Laboratory of Precision Medicine for Viral Diseases,Liuzhou 545006,China;Guangxi Key Laboratory of Biotechnology Research for Clinical Diseases,Liuzhou 545006,China;Department of Radiology,Liuzhou People's Hospital,Liuzhou 545006,China)
出处
《成都医学院学报》
CAS
2023年第5期574-578,共5页
Journal of Chengdu Medical College
基金
广西壮族自治区卫生和计划生育委员会项目(No:Z20170671)。
