肌酸激酶同工酶POCT检测系统的性能评价

The creatine kinase isoenzyme POCT method detection system performance evaluation

目的评价Triage Metet荧光免疫干式快速定量检测系统检测肌酸激酶同工酶(CK-MB)的精密度、正确度,以确保床边检验(POCT)结果的可靠性。方法采用美国临床与实验室标准化协会(CLSI)EP5-A2文件进行精密度验证,采用EP9-A2文件对Triage Metet荧光免疫干式快速定量分析仪与mini VIDAS全自动荧光免疫分析仪进行方法学比对,验证正确度。结果 CK-MB均值为5.00、39.10ng/mL时CV批内分别为3.40%、0.79%,CV总分别为3.40%、1.07%,均小于厂家声明的不精密度;CK-MB在两仪器的比对结果相关性良好(r2=0.998 6,P<0.05),CK-MB的医学决定水平分别为15、90,相对偏差(SE%)分别为2.53%、0.17%,均小于1/4CLIA′88的允许误差(30%)。结论美国Biosite Biagnostics公司生产的Triage Metet荧光免疫干式快速定量检测系统测定CK-MB的精密度、正确度性能良好,可满足临床需求。

Objective To Evaluate the precision and accuracy of triage metet fluorescence immunoassay dry quick quantitative detection system in the detection of creatine kinase isoenzyme（CK-MB） to ensure the reliability of bedside testing（POCT） results.Methods The American clinical and Laboratory Standards Institute（CLSI） EP5-A2 file was applied in precision verification,the EP9-A2 file was applied in the method comparison between Triage Metet fluorescence immunoassay dry fast quantitative analyzer and mini VIDAS automated fluorescence immunoassay analyzer,and verify the correctness.Results When the mean CK-MB was 5,39.10 ng/mL,the CV with a group were 3.40,0.79 respectively,CV among groups 3.40,1.07 respectively,which were less than manufacturers′ declaration of imprecision;CK-MB results in two instrument were correlated well（r2=0.998 6,P＆lt;0.05）,When the medical decision level of CK-MB were 15 and 90,relative standard deviation SE% were 2.53% and 0.17% respectively,which are less than 1/4 allowable error of CLIA′88（30%）.Conclusion The triage metet fluorescence immunoassay dry quick quantitative detection system produced by United States Biosite Biagnostics are with good precision and accuracy in the detection of CK-MB,which meets the clinical needs.