2种酶免疫方法在大型生化仪上检测药物浓度的应用评估

摘要

目的 评估均相酶免疫法与酶放大免疫法测定血清中苯妥英、丙戊酸、茶碱、地高辛、甲氨蝶呤、卡马西平、霉酚酸及全血环孢霉素A 8种药物浓度的一致性.方法 用均相酶免疫法和酶放大免疫法检测BIO-RAD 3个水平及原厂的质控品,计算批内、批间精密度.收集用于每种药物浓度检测的临床样本120例,其中异常样本超过30%,另每种药物再收集30例同源血浆样本(除环孢霉素A外),在SIEMENS ADVIA 2400全自动生化分析仪上用2种检测方法平行测定,观察2种方法检测临床样本的一致性.结果 均相酶免疫法和酶放大免疫法检测质控品批内、批间精密度,结果均在控且稳定性良好.2种检测方法测定环孢霉素A、苯妥英、丙戊酸、茶碱、地高辛、甲氨蝶呤、卡马西平及霉酚酸浓度的总体相关性较好(r值分别为0.997、0.993、0.997、0.996、0.988、0.994、0.999、0.997),各回归方程检验均具有统计学意义(P<0.001).2种检测方法测定结果差异均无统计学意义(P>0.05).2种检测方法在各药物医学决定水平处的预期偏移均小于规定允许误差范围.除环孢霉素A外,其余药物检测同源血清与血浆样本结果的一致性好,回归方程检验均有统计学意义(P<0.01),且配对t检验显示差异均无统计学意义(P>0.05).结论 均相酶免疫法和酶放大免疫法在SIEMENS ADVIA 2400全自动生化分析仪上检测苯妥英、丙戊酸、茶碱、地高辛、甲氨蝶呤、卡马西平、霉酚酸及环孢霉素A 8种药物浓度具有较好的一致性.%Objective To evaluate the consistency of homogeneous enzyme immunoassay and enzyme-amplified immunoassay in the determinations of phenytoin,valproic acid,theophylline,digoxin,methotrexate, carbamazepine and mycophenolic acid in serum and cyclosporine A in whole blood with 8 drug concentrations. Methods Homogeneous enzyme immunoassay and enzyme-amplified immunoassay were used to determine BIO-RAD with 3 concentrations and original quality control products,and the within-run and between-run precisions were calculated. A total of 120 clinical samples were collected for each drug concentration,which more than 30%of them were abnormal. Except for cyclosporine A,30 homologous plasma samples were collected for each drug concentration. Using SIEMENS ADVIA 2400 automatic biochemical analyzer,homogeneous enzyme immunoassay and enzyme-amplified immunoassay were performed parallelly,and the consistency of them was evaluated. Results The within-run and between-run precisions of homogeneous enzyme immunoassay and enzyme-amplified immunoassay were good,and there was a good stability. The overall correlation of each drug concentration was good,and r were 0.997 for cyclosporine A,0.993 for phenytoin,0.997 for valproic acid,0.996 for theophylline, 0.988 for digoxin,0.994 for methotrexate,0.999 for carbamazepine and 0.997 for mycophenolic acid. All the regression equations were significant statistically (P<0.001). There was no statistical significance for the results of the 2 methods(P>0.05). The expected bias of each drug concentration at medical decision level was in allowable error range. The consistency of homologous serum and plasma samples was good,except for cyclosporine A, and each regression equations were significant statistically(P<0.01),and the difference of paired t-test was not significant statistically (P>0.05). Conclusions The results of phenytoin,valproic acid,theophylline,digoxin, methotrexate,carbamazepine,mycophenolic acid and cyclosporine A with 8 drug concentrations have good consistency between the 2 methods by SIEMENS ADVIA 2400 automatic biochemical analyzer.