CMIA、FPIA、MEIA与EMIT测定血药浓度的比较分析

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（CsA）、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、CsA、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，Y_EMIT=1.172X_CMIA+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，Y_EMIT=1.259X_FPIA-4.671（r=0.97）；CsA，Y_EMIT=0.832X_FPIA+17.63（r=0.97）；CBZ，Y_EMIT=1.156X_FPIA-2.657（r=0.98）；MEIA与EMIT比较，测定结果有相关性：DIG，Y_EMIT=0.634X_MEIA+0.018（r=0.91）；其中CsA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、CsA、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。

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

Objective: To compare the consistency of Chemiluminesent Microparticle Immunoassay (CMIA), 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 patients. Results: The VPA concentrations assayed by EMIT were good linearly correlated with that by CMIA, YEMIT =1.172XCMIA+0.227 (r=0.97), and the concentrations determined by EMIT were 17.49% higher on average. FPIA compared to EMIT, the results had a 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 to EMIT, the results had correlation: DIG, YEMIT =0.634XMEIA+0.018 (r=0.91). Among them, CsA concentrations determined by EMIT were lower by average 2.08%, DIG concentrations were significantly lower by average 35.91%, but VPA concentrations were higher by average 16.83%, CBZ concentrations were higher by average 3.07%. Conclusion: There were significant differences (P<0.05) between CMIA with EMIT in assaying VPA concentration, between FPIA with EMIT in assaying VPA, CsA, CBZ concentrations, and between MEIA with EMIT in assaying DIG concentration, which suggest that we should pay attention to the discrepancy in clinical application.