化学发光微粒子免疫法和酶放大免疫法检测环孢素A全血浓度的相关性分析

目的 通过化学发光微粒子免疫法（CMIA）和酶放大免疫法（EMIT）检测环孢素A全血浓度，评价2种方法检测结果的准确性和相关性。方法 CMIA和EMIT检测低、中、高3个全血免疫抑制剂质控物，进行准确度和批内、批间精密度分析；已知浓度的环孢素A（49.5，155.2，395.8，500.0，995.0，1 390.1 ng·mL^-1）加入到不含环孢素A全血样本中，检测后计算结果回收率；测定100份环孢素A患者全血样本，测定值用Deming法进行线性回归分析和Bland-Altman法计算偏倚。结果 CMIA低、中、高3个全血免疫抑制剂质控物准确度相对误差分别为5.8%，5.2%，9.1%，其批内和批间的变异系数分别为7.4%，6.9%，8.6%和10.1%，11.3%，8.7%，CMIA回收率分别为91%，95%，103%，102%，102%，104%；EMIT低、中、高3个全血免疫抑制剂质控物的相对误差分别为2.8%，2.3%，4.3%，其批内和批间的变异系数分别11.2%，5.9%，5.7%和11.3%，9.2%，8.3%，EMIT回收率分别为90%，92%，97%，98%，99%，102%；CMIA和EMIT平均差异偏倚21.7 ng·mL^-1（95% CI：-125.1~168.4 ng·mL^-1），EMIT测定值/CMIA测定值平均为0.951（95% CI：0.56~1.34），EMIT测定结果平均低于CMIA 5%左右。结论 CMIA和EMIT检测环孢素A全血浓度符合免疫分析精密度的要求，2种方法的检测结果相关性好，临床合理调整用药剂量时应考虑检测方法类型不同造成的影响。

Correlation Analysis of Determination of Whole Blood Cyclosporin A Concentration by CMIA and EMIT

OBJECTIVE To assess the accuracy and correlation between chemiluminescent microparticle immunoassay(CMIA) and enzyme multiplied immunoassay technique(EMIT) in the determination of cyclosporine A(CSA) concentration in whole blood. METHODS The low, medium and high level of whole blood immunosuppressant control were determined by CMIA and EMIT, then the accuracy, intra-assay and inter-assay precision of each method were analyzed. The known concentrations of CSA(49.5, 155.2, 395.8, 500.0, 995.0 and 1 390.1 ng·ml^-1) were added into the whole blood sample without CSA and measured, then the recovery rates of testing results were calculated. Whole blood samples of 100 patients were detected, the results were analyzed by Deming regression for linear regression analysis and analyzed by Bland-Altman for calculating bias. RESULTS The relative error of the low, medium and high level of whole blood immunosuppressant control measured with CMIA was 5.8%, 5.2% and 9.1%, the intra-assay coefficient of variation(CV) was 7.4%, 6.9% and 8.6%, the inter-assay CV was 10.1%, 11.3% and 8.7%, and the recovery rate was 91%, 95%, 103%, 102%, 102% and 104%, respectively. While in EMIT, it was observed that the relative error was 2.8%, 2.3% and 4.3%, the intra-assay CV was 11.2%, 5.9% and 5.7%, the inter-assay CV was 11.3%, 9.2% and 8.3%, and the recovery rate was 90%, 92%, 97%, 98%, 99% and 102%, respectively. The bias of mean difference between CMIA and EMIT was 21.7 ng·mL^-1(95% CI:-125.1-168.4 ng·mL^-1). The relative value of EMIT/CMIA was 0.951(95% CI:0.56-1.34). The determination results of EMIT was 5% lower than that of CMIA in average. CONCLUSION Determination of whole blood CSA concentration by CMIA and EMIT meet the requirement of accuracy in immune analysis. The results showed a good correlation between CMIA and EMIT. The effects of different types of detection methods should be taken into consideration for the rational dosage adjustment of drugs in clinic.