化学发光微粒子免疫法在测定他克莫司血药浓度中的作用

摘要

Objective To analyze and evaluate the effect of chemiluminescent microparticle immunoassay (CMIA) on determination of tacrolimus .Methods 60 cases of blood samples were collected from patients received liver or renal transplantation in the First Affiliated Hospital of Xi ′an Jiaotong University ,and detected the blood con‐centration of tacrolimus by CMIA .Architect i2000 automatic immunoassay system was used to detect the quality con‐trols of tacrolimus for 5 d in a row ,so as to calculate the slope ,nonlinearity ,intercept ,driftance and contamination rate of tacrolimus fixed value quality control .Results After 5‐day continuous detection ,the results showed that the deviations between measured values and target values of the quality controls with different tarcrolimus concentrations as well as the coefficient of variation (CV ) were within the allowable range .The average intercept ,nonlinearity , slope ,driftance and contamination rate of 5‐day continuous detection were 12 .17 ,0 .65 ,7 .62 ,0 .15 ,and - 0 .12% ,re‐spectively .The differences both of slope and intercept were significant (P< 0 .05) .The contamination rate ,nonlinear‐ity ,driftance ,and the slope correction with calibration factors (median value‐low value) had no significantly difference (P> 0 .05) .Among 335 cases of samples ,there were 281 cases (83 .89% ) ,within the tarcrolimus therapeutic range (3 - 20 μg/L) .Conclusion The CMIA determination of tacrolimus has good tightness and accuracy ,and its perform‐ance indicators also meet the clinical basic requirements .It is a preferred method for the detection of tacrolimus con‐centration in blood .%目的：评价分析化学发光微粒子免疫法（CMIA）在测定他克莫司血药浓度检测中的作用。方法回顾性分析西安交通大学第一附属医院收集的60例肝肾移植患者血液标本，并将收集的血液标本均实施 CMIA 测定他克莫司血药浓度，同时采用 Architect i2000自动免疫分析系统对他克莫司定值质控品连续测定5 d ，计算他克莫司定值质控品斜率、非线性度、截距、漂移度和携带污染率。结果连续测定5 d 各水平质控品测定值和靶值的偏差在允许范围内，总不精密度（CV）也在可以接受的范围内；同时连续测定5 d 他克莫司质控品截距平均值为12．17，非线性度平均值为0．65，斜率平均值为7．62，漂移度平均值为0．15，携带污染率为－0．12％，斜率和截距差异均有统计学意义（P＜0．05），携带污染率、非线性度及漂移度和用刻度因子（中值－低值）进行校正后斜率差异无统计学意义（P＞0．05）。335份血液标本浓度在3～20μg／L 的治疗浓度范围内有281份，占83．89％。结论 CMIA 在他克莫司免疫抑制剂血药浓度测定中具有良好的精密度和准确度，同时性能指标也符合临床基本要求，可以作为他克莫司免疫抑制剂血药浓度检测首选方法。