摘要
目的评价基蛋生物Getein1600荧光免疫定量分析仪分析CK-MB的正确度、精密度、线性范围,为POCT的应用提供质量保证。方法参考美国临床与实验室标准化协会(CLSI)EP9-A2文件对基蛋生物Getein1600荧光免疫定量分析仪与雅培I2000全自动免疫分析仪进行方法学比对,验证正确度;采用EP15-A进行精密度验证;采用EP6-A对线性范围进行验证。结果CK-MB在两台仪器的比对结果相关性良好(R=0.9936,P>0.05);CK-MB均值为4.58、10.47、14.99时总CV分别为8.75%、9.29%、6.45%。CK-MB项目线性范围参考品理论值与测试平均值回归系数R2=0.990,在3.06~72.51ng/mL浓度区间呈线性,该分析测量范围通过验证。结论基蛋生物Getein1600荧光免疫定量分析仪性能验证良好,与厂家说明书声明相符。
Objective To evaluate the accuracy,precision and linear range of CK-MB analyzed by Getein1600 fluorescence immunodetermination analyzer and to provide the quality assurance for the application of POCT.Methods According to the American Association for Clinical and Laboratory Standardization(CLSI)EP9-A2 document,the comparison analysis between Getein1600 fluorescence immunoassay and the Abbott I2000 automatic immunoassay was carried out,and the accuracy was verified.We used EP15-A for precision verification and EP6-A was used to verify the linear range.Results The consistence ratio of CK-MB between the two instruments was good( R=0.9936,P >0.05);The total CV were 8.75 %,9.29 %,and 6.45 %,respectively.The theoretical value of the CK-MB project linear range reference product and the test mean regression coefficient R 2=0.990 showed a linear relationship within the concentration range of 3.06-72.51 ng/mL,and the range of measurement of this analysis was verified.Conclusion Getein1600 fluorescence immunodetermination analyzer has a good performance.
作者
吴允凤
刘玉兰
刘展
孙艳艳
WU Yun-feng;LIU Yu-lan;LIU Zhan;SUN Yan-yan(Clinical Laboratory,Beijing Shijingshan Hospital,Teaching Hospital Affiliated to Capital Medical University,Beijing 100041,China)
出处
《标记免疫分析与临床》
CAS
2019年第7期1211-1213,共3页
Labeled Immunoassays and Clinical Medicine
关键词
POCT
肌酸激酶同工酶
性能验证
Point of care testing
Creatine kinase isoenzyme
Performance evaluation
