全自动生化分析仪检测肌酸激酶同工酶质量分析性能验证  

A Performance Evaluation of Creatine Kinase Isoenzyme Quality Detection by an Automatic Biochemical Analyzer

作　　者：郭丽丽[1] 郭胜利[2] 李守霞[1] 陈丁莉[1] 孙彩霞[1] 张彦青[1] 宋学东[1] 秦志梅[1] 张海丽[1] 平慧[1] 郭红霞[1] 任郁英[1] GUO Lili;GUO Shengli;LI Shouxia;CHEN Dingli;SUN Caixia;ZHANG Yanqing;SONG Xuedong;QIN Zhimei;ZHANG Haili;PING hui;GUO Hongxia;REN Yuying(Handan City Center Hospital Laboratory, Handan 056001,China;Handan Iron and Steel Group Company StaffHospital Laboratory, Handan 056001,China)

机构地区：[1]河北省邯郸市中心医院检验科,河北邯郸056001 [2]邯郸钢铁集团有限责任公司职工医院,河北邯郸056001

出　　处：《标记免疫分析与临床》2020年第3期522-527,共6页Labeled Immunoassays and Clinical Medicine

摘　　要：目的验证全自动生化分析仪定量检测系统检测肌酸激酶同工酶质量(CKMB mass)的分析性能,确保检验结果的准确。方法参照CLSI系列相关文件、国家相关卫生行业标准、并结合实际情况,对定量检测系统的精密度、正确度、线性范围、临床可报告范围、生物参考区间等分析性能进行验证、评价,将实验室验证结果与质量允许范围进行比较;并对CKMB/CK活性升高或倒置现象进行验证。结果贝克曼AU5400全自动生化分析仪测定CKMB mass浓度在14.185、36.467 ng/mL时,实验室批内不精密度(CVr)分别为2.778%、2.172%,总不精密度(CVl)分别为4.507%、2.255%;与罗氏E602全自动电化学发光分析仪测定CKMB mass进行患者样本比对,回归方程Y=1.0277 X-0.5778,R2=0.9846,相关性良好,5、10、15、90 ng/mL浓度水平处的预期偏倚分别为-8.8%、-3.0%、-1.1%、2.1%,可接受;线性范围为1.865~186.34 ng/mL;临床可报告范围为1.865~1490.72 ng/mL;生物参考区间0~5 ng/mL适用于本实验室;能够很好的纠正实验室CKMB/CK活性假性升高或倒置的现象。结论贝克曼AU5400全自动生化分析仪测定CKMB mass的精密度、正确度、线性范围、临床可报告范围、参考区间等性能良好,能够规范检测、确保检测质量,满足临床需求。Objective To evaluate the analytical performance of CKMB mass detected by an automatic biochemical analyzer quantitative detection system,so to confirm the accuracy of the results.Methods Referring to the CLSI series document:“National relevant health industry standards”and also by considering our actual working environment,five aspects(including the precision,accuracy,linear range,clinical reportable range and biological reference interval,et al.)of CKMB mass were evaluated.Results were then compared with the allowable range of quality,and to verify the inversion of CKMB/CK.Results CKMB mass was measured by Beckman AU5400 automatic biochemical analyzer.When CKMB levels were at 14.185 and 36.467ng/mL,the Intra-batch unrefined density(CVr)were 2.778%,2.172%,and the total unrefined density(CVl)were 4.507%,2.255%,respectively.When compared with patient samples with CKMB mass measured by Roche E602 automatic electrochemiluminescence analyzer,the review equation was:Y=1.0277 X-0.5778,with R2=0.9846,and showed a good correlation.The expected bias at the concentration levels of 5,10,15,90 ng/mL was-8.8%,-3.0%,-1.1%,and 2.1%respectively,which was acceptable.The linear range was 1.865-186.34ng/mL.The clinical reportable range was 1.865-1490.72ng/mL.The biological reference interval was 0 to 5ng/mL,which was suitable for our laboratory.It was able to correct the inversion of CKMB/CK in our laboratory very well.Conclusion Determination of CKMB mass by Beckman AU5400 automatic biochemical analyzer is evaluated in the current study.The main performances of the detection system are accorded with the requirements,which is able to standardize detection,ensure the quality of testing,and meet the clinical need.

关 键 词：全自动生化分析仪 肌酸激酶同工酶质量 性能验证 

分 类 号：R392-33[医药卫生—免疫学]