CAJ | 학술논문

目的：评价2种分析方法同时检测中国肾移植患者的全血中西罗莫司浓度的差异。方法用高效液相色谱质谱联用法（LC-MS/MS）和化学发光微粒子免疫分析法（ CMIA）分别测定中国肾移植患者全血西罗莫司浓度，评价2种分析方法的相关性。结果 LC-MS/MS法专属性强、精密度、稳定性好，能满足临床检测要求。2种方法测得的数据相关系数为0.963（ P＜0.05），2组数据间存在相关性（n＝78）。当西罗莫司浓度在2～10 ng· mL-1时，2种方法测定的平均偏差为2.8 ng· mL-1。结论 LC-MS/MS和CMIA测定西罗莫司全血浓度的分析方法存在相关性；同一份样本用CMIA测定的浓度均值比LC-MS/MS法测定的值高。
목적：평개2충분석방법동시검측중국신이식환자적전혈중서라막사농도적차이。방법용고효액상색보질보련용법（LC-MS/MS）화화학발광미입자면역분석법（ CMIA）분별측정중국신이식환자전혈서라막사농도，평개2충분석방법적상관성。결과 LC-MS/MS법전속성강、정밀도、은정성호，능만족림상검측요구。2충방법측득적수거상관계수위0.963（ P＜0.05），2조수거간존재상관성（n＝78）。당서라막사농도재2～10 ng· mL-1시，2충방법측정적평균편차위2.8 ng· mL-1。결론 LC-MS/MS화CMIA측정서라막사전혈농도적분석방법존재상관성；동일빈양본용CMIA측정적농도균치비LC-MS/MS법측정적치고。
Objective To evaluate the two analytical methods for sirolimus concentration detection in whole blood of Chinese renal transplant patients.Methods The LC -MS/MS method and chemiluminescent microparticle immunoassay (CMIA) were used to detect the whole blood sirolimus concen-trations in Chinese renal transplant patients respectively and correlation of the two methods was analyzed.Results LC-MS/MS method was charac-terized as specificity , good precision and stability , which met the require-ments of clinical testing.Statistical analysis of the two methods showed that:the correlation coefficient was 0.963 (P <0.05,n=78).An average devia-tion of 2.8 ng· mL-1 was shown when whole blood sirolimus concentrations ranging from 2 to 10 ng · mL-1 was detected using the two methods.Con-clusion There is a correlation between the LC -MS/MS and CMIA to de-termine whole blood sirolimus concentrations in Chinese renal transplant pop-ulation.An average concentration values of the same sample is higher when using CMIA determination compared with LC -MS/MS method.