药学与临床研究
藥學與臨床研究
약학여림상연구
Pharmaceutical and Clinical Research
2015年
5期
437-442
,共6页
朱婷婷%储小曼%赵宇蕾%芮建中%周国华
硃婷婷%儲小曼%趙宇蕾%芮建中%週國華
주정정%저소만%조우뢰%예건중%주국화
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
化學髮光微粒子免疫分析法%熒光偏振免疫分析法%微粒子捕捉免疫分析法%酶擴大免疫分析法%治療藥物鑑測
화학발광미입자면역분석법%형광편진면역분석법%미입자포착면역분석법%매확대면역분석법%치료약물감측
Chemiluminesent microparticle immunoassay%Fluorescence polarization immunoassay%Mi-croparticle enzyme immunoassay%Enzyme multiplied immunoassay technique%Therapeutic drug monitoring
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，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）；CsA，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。
目的：分析比較化學髮光微粒子免疫分析法（CMIA）、熒光偏振免疫分析法（FPIA）、微粒子捕捉免疫分析法（MEIA）和酶擴大免疫分析法（EMIT）測定血清丙戊痠（VPA）、全血環孢黴素A（CsA）、血清卡馬西平（CBZ）和血清地高辛（DIG）濃度的一緻性。方法：通過測定高、中、低濃度質控樣品，評價各方法的準確度及精密度，併對臨床患者的VPA、CsA、CBZ和DIG樣本進行測定，比較4種方法測定結果的相關性。結果：CMIA與EMIT（測定值為函數Y）比較，測定VPA的結果具有良好的相關性和差異性，YEMIT=1.172XCMIA+0.227（r=0.97），EMIT的測定結果比CMIA平均高17.49%。 FPIA與EMIT比較，測定結果具有良好的相關性：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與EMIT比較，測定結果有相關性：DIG，YEMIT=0.634XMEIA+0.018（r=0.91）；其中CsA的EMIT 測定結果比FPIA 平均低2.08%，DIG 的EMIT 測定結果比MEIA 平均低35.91%，而VPA的EMIT測定結果比FPIA平均高16.83%、CBZ的EMIT測定結果比FPIA平均高3.07%。結論：CMIA 測定 VPA 血藥濃度、FPIA 測定 VPA、CsA、CBZ 及 MEIA 測定 DIG 血藥濃度與EMIT的測定結果，存在差異性（P<0.05），臨床應用中應予以關註併作相應調整。
목적：분석비교화학발광미입자면역분석법（CMIA）、형광편진면역분석법（FPIA）、미입자포착면역분석법（MEIA）화매확대면역분석법（EMIT）측정혈청병무산（VPA）、전혈배포매소A（CsA）、혈청잡마서평（CBZ）화혈청지고신（DIG）농도적일치성。방법：통과측정고、중、저농도질공양품，평개각방법적준학도급정밀도，병대림상환자적VPA、CsA、CBZ화DIG양본진행측정，비교4충방법측정결과적상관성。결과：CMIA여EMIT（측정치위함수Y）비교，측정VPA적결과구유량호적상관성화차이성，YEMIT=1.172XCMIA+0.227（r=0.97），EMIT적측정결과비CMIA평균고17.49%。 FPIA여EMIT비교，측정결과구유량호적상관성：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）；MEIA여EMIT비교，측정결과유상관성：DIG，YEMIT=0.634XMEIA+0.018（r=0.91）；기중CsA적EMIT 측정결과비FPIA 평균저2.08%，DIG 적EMIT 측정결과비MEIA 평균저35.91%，이VPA적EMIT측정결과비FPIA평균고16.83%、CBZ적EMIT측정결과비FPIA평균고3.07%。결론：CMIA 측정 VPA 혈약농도、FPIA 측정 VPA、CsA、CBZ 급 MEIA 측정 DIG 혈약농도여EMIT적측정결과，존재차이성（P<0.05），림상응용중응여이관주병작상응조정。
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.
