酶增强免疫分析法与微粒子酶联免疫吸附法检测他克莫司药物浓度的结果对比研究

The result comparison research of the tacrolimus concentration by enzyme-multiplied immunoassay technique and microparticle enzyme immunoassay

目的对酶增强免疫分析法(EMIT)与微粒子酶联免疫吸附法(MEIA)进行比对实验,评估SYVAViva-E临床化学分析仪(简称SYVA Viva-E)和Abbott IMX分析仪(简称Abbott IMX)2种检测系统测定他克莫司(FK506)药物浓度的一致性。方法将Tac/Csa CONTROL质控品分别用SYVA Viva-E(EMIT)和Abbott IMX(MEIA)进行批内、批间精密度测定。FK506的靶值(检测范围):A1水平为4.3(2.1～6.5)ng/mL、A2水平为8.9(5.3～12.5)ng/mL、A3水平为18.0(14.0～22.0)ng/mL。将158份临床患者样本分为极低浓度(0.1～<2.0 ng/mL)、低浓度(2.0～<8.0 ng/mL)、中浓度(8.0～<14.0 ng/mL)、高浓度(14.0～<20.0 ng/mL)和极高浓度(20.0～24.0 ng/mL)5个组,用SYVA Viva-E和Abbott IMX平行测定FK506浓度,观察2种检测系统测定临床样本的相关性。结果当FK506浓度处于A1水平时,SYVA Viva-E的批内、批间精密度及检测结果均值均高于Abbott IMX(P<0.05);处于A2、A3水平时,2种检测系统批内、批间精密度及检测结果均值相近,差异无统计学意义(P>0.05)。Abbott IMX的检测精密度优于SYVA Viva-E。当临床样本浓度<8.0 ng/mL时,SYVAViva-E检测结果的均值比Abbott IMX约高1.0 ng/mL,二者比较差异有统计学意义(P<0.01),与测定质控品的结果一致;当样本浓度≥8.0 ng/mL时,SYVA Viva-E检测结果的均值与Abbott IMX相近,二者比较差异无统计学意义(P>0.05)。2种检测系统测定临床样本的总体相关性较好(r=0.977),但SYVA Viva-E检测结果均略高于Abbott IMX。结论应用EMIT检测FK506时,其检测结果略高于MEIA,尤其在低浓度范围更加明显。2种检测系统在检测FK506浓度时可能存在系统偏差。

Objective To evaluate the coincidence of the results of tacrolimus（FK506） concentration determined by enzyme-multiplied immunoassay technique（EMIT） using the SYVA Viva-E clinical biochemical analyzer（SYVA Viva-E） and by microparticle enzyme immunoassay（MEIA） using the Abbott IMX analyzer（Abbott IMX）.Methods The within-run and between-run precisions were detected with quality control material Tac/Csa by SYVA Viva-E（EMIT） and by Abbott IMX（MEIA）.The FK506 target values as determination range were A1=4.3（2.1-6.5）ng/mL,A2=8.9（5.3-12.5） ng/mL and A3=18.0（14.0-22.0） ng/mL.158 clinical samples were collected as clinical sample group and were classified into 5 concentration groups：extremely low concentration（0.1-2.0 ng/mL）,low concentration（2.0-8.0 ng/mL）,middle concentration（8.0-14.0 ng/mL）,high concentration（14.0-20.0 ng/mL） and extremely high concentration（20.0-24.0 ng/mL）.SYVA Viva-E and Abbott IMX were used to determine the FK506 concentration of equal rank.The correlation of the 2 analyzers detecting clinical samples was observed.Results In the A1 concentration range,the within-run and between-run precisions and the average results by SYVA Viva-E were both higher than those by Abbott IMX（P0.05）.In the A2 and A3 concentration ranges,the within-run and between-run precisions and the average results by SYVA Viva-E were closed to those by Abbott IMX with no significant difference（P0.05）.The precision by Abbott IMX was better than that by SYVA Viva-E.In the clinical sample group,when the concentration was 8.0 ng/mL,the average result by SYVA Viva-E was higher about 1.0 ng/mL than that by Abbott IMX,and it had significant difference（P0.01）.The result was consistent with that of the control group.When the concentration was≥8.0 ng/mL,the average result by SYVA Viva-E was closed to that by Abbott IMX,and it had no significant difference（P0.05）.The overall correlation coefficient of the result was good（r=0.977）,but the result by SYVA Viva-E was slightly higher than that by Abbott IMX.Conclusions The FK506 result by EMIT is slightly higher than that by MEIA,especially in the low concentration range.The FK506 results by 2 detection systems possibly have system error.