化学发光微粒子免疫法测定血药浓度检测偏差的影响因素分析  

Deviation factors for determination of therapeutic drug concentrations via chemiluminescent particle immunoassay

作　　者：陈艳[1] 杨凡 姜楠[1] 王天琳[1] CHEN Yan;YANG Fan;JIANG Nan;WANG Tian-lin(Department of Pharmacy,Medical Supplies Center of PLA General Hospital,Beijing 100853,China)

机构地区：[1]解放军总医院医疗保障中心药剂科,北京100853

出　　处：《军事医学》2023年第1期51-55,64,共6页Military Medical Sciences

摘　　要：目的分析化学发光微粒子免疫分析法测定血药浓度结果的影响因素。方法收集服用环孢素A、他克莫司、丙戊酸、万古霉素和地高辛患者的血液标本,利用全自动化学发光微粒子免疫分析仪分别测定各影响因素及不同条件下血药浓度值和校准质控值。结果环孢素A、他克莫司、丙戊酸、万古霉素和地高辛试剂校准后,质控“打靶”良好。环孢素A和他克莫司检测试剂上机时间接近2个月时,检测结果下降可达10%~16%;丙戊酸、万古霉素和地高辛检测试剂上机时间接近3个月时,检测结果下降可达15%~20%。环孢素A血药浓度样本冷藏储存超过7 d,结果偏倚较大,应废弃;地高辛血药浓度样本保存于室温或冷藏时均不建议超过3 d;丙戊酸和万古霉素样本可室温保存3 d或冷藏7 d。预处理后的环孢素A和他克莫司样本提取液应在2 h内尽快上机检测。结论对检测试剂需精准定标并及时使用,对样本需科学储存并及时预处理检测,可有效减少化学发光微粒子免疫法测定血药浓度的结果偏差。Objective To analyze the influencing factors of deviation during determination of therapeutic drug concentrations using chemiluminescent particle immunoassay(CMIA).Methods The concentrations of cyclosporine A,tacrolimus,valproic acid,vancomycin and digoxin were measured in clinical samples and quality controls using CMIA respectively.Results After reagent calibration,the quality controls of cyclosporine A,tacrolimus,valproic acid,vancomycin and digoxin"hit the targets"accurately.The concentrations of cyclosporine A and tacrolimus decreased by 10%-16%when the reagents were used for 2 months.The concentrations of valproic acid,vancomycin and digoxin decreased by15%-20%when the reagents were used for 3 months.Blood concentration samples of cyclosporine A had to be discarded after being stored for more than 7 days at 2-8℃,and digoxin samples should not be stored for more than 3 days at room temperature or 2-8℃.Pre-treated cyclosporine A and tacrolimus samples should be tested as soon as possible within 2 h.Conclusion Accurate calibration and immediate use of reagents plus proper storage,quick preprocessing and testing of samples can effectively reduce deviation of drug concentrations during determination with CMIA.

关 键 词：治疗药物监测 化学发光微粒子免疫分析法 偏差 影响因素 

分 类 号：R969.1[医药卫生—药理学]