不同检测系统的性激素六项检测性能比对分析  

Comparative analysis of sex hormone detection performance of different detection systems

作　　者：卢诗云 刘敏 Lu Shiyun;Liu Min(TaiYuan KingMed Center for Clinical Laboratory,Taiyuan Shanxi 030032,China)

机构地区：[1]太原金域临床检验所有限公司,山西太原030032

出　　处：《中华临床实验室管理电子杂志》2023年第3期133-138,共6页Chinese Journal of Clinical Laboratory Management(Electronic Edition）

摘　　要：目的通过对比进口A和国产B两个检测系统在性激素六项检测中的性能,评价国产B全自动化学发光仪是否满足临床检测要求及目前国产化学发光分析仪在性激素检测中的应用价值,挖掘国产化学发光分析仪的市场优势。方法采用国产B检测系统分别验证孕酮(P)、雌二醇(E2)、促黄体生成素(LH)、卵泡刺激素(FSH)、垂体泌乳素(PRL)、睾酮(T)的精密度和线性范围。同时对国产B检测系统与参考系统进行相关性比对、回收试验比对以及抗干扰性能比对。参考系统为实验室在用的进口仪器(进口A)及其配套试剂。结果国产B仪器P、E2、LH、FSH、PRL和T的精密度验证批内CV(%)为0.832~3.586,批间CV(%)为1.290~3.876。批内不精密度均≤1/4 TEa(±6.25%)、总不精密度均≤1/3 TEa(±8.33%);线性范围验证均符合要求;国产B与进口A的检测结果之间的相关系数为0.98~0.99,均R^(2)≥0.95;国产B检测系统回收率为96%~107%,进口A检测系统回收率为97%~108%,两者均在±10%的可接受范围内;进口A和国产B干扰试验结果均符合厂家要求。结论进口A和国产B检测系统对性激素六项的检测结果具有较好的一致性,可为临床提供可靠的检测结果。国产化学发光仪设备技术达到较高水平,具有独特的市场优势。Objective By comparing the performance of two detection systems,imported A and domestic B,in the six detection items of sex hormones,to evaluate whether the automatic chemiluminescence instrument of domestic B meets the clinical requirements and the application value of domestic chemiluminescence analyzer in the detection of sex hormones,and to explore the market advantages of domestic chemiluminescence analyzer.Methods The domestic B was used to verify the precision and linear range of progesterone(P),estradiol(E2),luteoprohormone(LH),follicle stimulating hormone(FSH),prolactin(PRL),testosterone(T).Domestic B compares the correlation,recovery test and anti-interference performance with the reference system.The reference system is an imported instrument(imported A)and its supporting reagents.Results Domestic B instruments P,E2,LH,FSH,PRL and T were 0.832~3.586,CV(%)1.290~3.876,1/4 TEa(±6.25%),total inprecision 1/3 TEa(±8.33%).Linear range validation met the requirements(see Table 2).Correlation coefficient between domestic B and imported A instruments was 0.98~0.99 and R^(2)≥0.95.The recovery rate of domestic B is 96%~107%,imported A is 97%~108%,imported A is slightly better than domestic B,both are within the acceptable range of±10%;the interference test results of imported A and domestic B meet the requirements of the manufacturer.Conclusions The results between imported A and domestic B,which can meet the clinical needs.Domestic chemiluminescence instrument equipment technology to reach a high level,has a unique market advantage.

关 键 词：性激素 化学发光分析仪 对比分析 

分 类 号：R44[医药卫生—诊断学]