CMIA、FPIA、MEIA与EMIT测定血药浓度的比较分析  

Comparison of CMIA, FPIA, MEIA with EMIT in Determination of Blood Drug Concentrations

作　　者：朱婷婷[1] 储小曼[1] 赵宇蕾[1] 芮建中[1] 周国华[1] 

机构地区：[1]南京军区南京总医院药理科,南京210002

出　　处：《药学与临床研究》2015年第5期437-442,共6页Pharmaceutical and Clinical Research

基　　金：江苏省第七批"六大人才高峰"资助项目(2010WSN-204)

摘　　要：目的:分析比较化学发光微粒子免疫分析法(CMIA)、荧光偏振免疫分析法(FPIA)、微粒子捕捉免疫分析法(MEIA)和酶扩大免疫分析法(EMIT)测定血清丙戊酸(VPA)、全血环孢霉素A(Cs A)、血清卡马西平(CBZ)和血清地高辛(DIG)浓度的一致性。方法:通过测定高、中、低浓度质控样品,评价各方法的准确度及精密度,并对临床患者的VPA、Cs A、CBZ和DIG样本进行测定,比较4种方法测定结果的相关性。结果:CMIA与EMIT(测定值为函数Y)比较,测定VPA的结果具有良好的相关性和差异性,YEMIT=1.172XCMIA+0.227(r=0.97),EMIT的测定结果比CMIA平均高17.49%。FPIA与EMIT比较,测定结果具有良好的相关性:VPA,YEMIT=1.259XFPIA-4.671(r=0.97);Cs A,YEMIT=0.832XFPIA+17.63(r=0.97);CBZ,YEMIT=1.156XFPIA-2.657(r=0.98);MEIA与EMIT比较,测定结果有相关性:DIG,YEMIT=0.634XMEIA+0.018(r=0.91);其中Cs A的EMIT测定结果比FPIA平均低2.08%,DIG的EMIT测定结果比MEIA平均低35.91%,而VPA的EMIT测定结果比FPIA平均高16.83%、CBZ的EMIT测定结果比FPIA平均高3.07%。结论:CMIA测定VPA血药浓度、FPIA测定VPA、Cs A、CBZ及MEIA测定DIG血药浓度与EMIT的测定结果,存在差异性(P<0.05),临床应用中应予以关注并作相应调整。Objective: To compare the consistency of Chemiluminesent Microparticle Immunoassay (CMI-A), Fluorescence Polarization Immunoassay (FPIA), Microparticle Enzyme Immunoassay (MEIA) with Enzyme Multiplied Immunoassay Technique (EMIT) in the determination of Cyclosporine A (CsA) in whole blood, and Valproic Acid (VPA), Carbamazepine (CBZ) and Digoxin (DIG) in serum. Methods: The accuracy and precision of each method were evaluated by assaying the high, medium and low concentration samples of quality control respectively. The correlations between CMIA, FPIA, MEIA with EMIT were determined by assaying the concentrations of CsA, VPA, CBZ and DIG in patient blood samples. Results: The VPA con-centrations assayed by EMIT were well linearly correlated with those by CMIA, YEMIT=1.172XCMIA+0.227 (r=0.97), and the concentrations determined by EMIT were 17.49% higher on average. FPIA compared with EMIT, the results showed good correlation: VPA, YEMIT=1.259XFPIA-4.671 (r=0.97); CsA, YEMIT=0.832XFPIA+17.63 (r=0.97); CBZ, YEMIT=1.156XFPIA-2.657 (r=0.98). MEIA compared with EMIT, the results showed corre-lation: DIG, YEMIT=0.634XMEIA+0.018 (r=0.91). For the concentrations determined by EMIT, CsA were aver-agely 2.08% lower than those by FPIA; DIG were significantly lower by 35.91% in average than by EMIT;but VPA were averagely 17% higher than those by CMIA or FPIA; CBZ were averagely 3.07% higher than those by FPIA. Conclusion: There were significant differences (P<0.05) between EMIT and CMIA, FPIA or MEIA in assaying VPA, CsA, CBZ or DIG concentrations, which suggest that we should pay attention to the discrepancy in clinical application.

关 键 词：化学发光微粒子免疫分析法 荧光偏振免疫分析法 微粒子捕捉免疫分析法 酶扩大免疫分析法 治疗药物监测 

分 类 号：R969.1[医药卫生—药理学]