两种方法检测血浆间甲肾上腺素的一致性比较

The Comparison of the Consistency of the Two Methods in the Detection of PlasmaMethinephrine

目的对高效液相色谱法串联质谱法(LC-MS/MS)和酶联免疫吸附法(ELISA)试剂盒检测变肾上腺素MN和去甲变肾上腺素NMN(MN和NMN两者合称间甲肾上腺素类物质MNs)进行对比实验,探讨两种方法检测结果的相关性和一致性,了解ELISA法试剂盒性能。方法分别收集若干例临床血浆标本,分别用ELISA法试剂盒配套的质控物,试剂和LC-MS/MS检测MNs,统计分析检测结果的相关性和一致性。结果两种检测系统的测定结果存在良好的线性关系,两者相关系数为分别为0.98和0.99。两种检测系统的测定结果在使用Bland-Altman统计后,几乎所有统计点都在95%的一致性界限内。证明两种检测系统的测定结果存在良好的一致性。且使用ELISA试剂盒检测不同浓度的MNs,批间差异和批内差异几乎都在15%以内,试剂盒精密度良好。结论 ELISA方法检测MNs的线性和检测范围符合说明书要求,可以实现方法学的替代。

Objective Using liquid chromatography -tandem mass spectrometry (LC-MS/MS)and Enzyme-linked immunosorbent assay(ELISA)to detect metanephrine and normetanephrine (combined term MNs),so to evaluate the correlation and consistency of the results of the two methods and further investigate the performance of the ELISA kit. Methods We randomly selected several cases of hospitalized patients plasma samples,and then used LC-MS/MS method and quality control materials,as well as the reagents matching the ELISA method,to determine levels of MNs ,respectively.The correlation and consistency between the results of two methods were then analyzed. Results There was a good linear relationship between the results of the two detection systems,and the correlation coefficients were 0.98 and 0.99,respectively.The measurement results of the two detection systems were almost all within the consistency limit of 95% using Bland-Altman statistics,suggesting a good consistency between the two detection systems.The ELISA kit was used to detect different concentrations of MNs.The differences of inter-assay and intra assay are almost all within 15%,indicating that the precision of kit was good. Conclusion The linear and detection range of ELISA kit for detecting MNs are in conformity with the instructions.The further samples could be tested with ELISA kits instead of LC-MS/MS.