酶扩大免疫测定技术与荧光偏振免疫法测定全血环孢素浓度的比较

目的:比较酶扩大免疫测定技术(EMIT)与荧光偏振免疫法(FPIA)测定全血环孢素浓度的差异。方法:通过分别测定高、中、低浓度标准质控品评价各方法的准确度及精密度,并对卫生部室间质控品及99份临床全血环孢素样本进行测定,比较2种方法测定结果的相关性。结果:EMIT与FPIA方法学的相对回收率分别在93.74%～105.73%与99.84%～102.26%之间,日内及日间精密度良好,RSD均小于10%,符合生物样品的测定要求。两方法测定结果具有良好的相关性Y=1.122 1 X+1.783 7,r=0.987,EMIT的测定结果大多低于FPIA测定结果。结论:EMIT法与FPIA法测定环孢素血药浓度结果存在显著性差异,临床应用中应予以关注并作相应调整。

Comparison of EMIT and FPIA in monitoring cyclosporin A in whole blood

OBJECTIVE To compare the difference of enzyme multiplied immunoassay technique(EMIT) and fluorescence polarization immunoassay(FPIA) in monitoring cyclosporine A(CsA) levels in whole blood.METHODS Recoveries and precisions of EMIT and FPIA were calculated by determining the different levels of CsA standard controls respectively.Samples of between-ward monitoring from Clinet and 99 samples from patients were determined by EMIT and FPIA respectively.Analyze the correlation of two methods.RESULTS The relative recoveries of the EMIT and FPIA were between the range of 93.74%-105.73% and 99.84%-102.26%,respectively.The RSD of EMIT and FPIA were all less than 10%,the requirement for biological sample determination in the Chinese Pharmacopoeia.The correlation of EMIT and FPIA was good and the regression equation was y=1.122 1x+1.783 7,r=0.987,The EMIT gave significantly lower values than FPIA.CONCLUSION There was significant difference between the results of two methods,and we should pay attention to the difference of CsA monitoring by EMIT and FPIA.