Fung Angela W S, Knauer Michael J, Blasutig Ivan M, Colantonio David A, Kulasingam Vathany
Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, M5S 1A8, Canada.
Department of Pathology and Laboratory Medicine, St. Paul's Hospital, Vancouver, BC, V6Z 1Y6, Canada.
F1000Res. 2017 Oct 13;6:1832. doi: 10.12688/f1000research.12775.2. eCollection 2017.
: Therapeutic drug monitoring of immunosuppressant drugs are used to monitor drug efficacy and toxicity and to prevent organ transplant rejection. This study evaluates the analytical performance of semi-automated electrochemiluminescence immunoassays (ECLIA) for cyclosporine (CSA), tacrolimus (TAC) and sirolimus (SRL) on the Roche cobas e 411 analyzer at a major transplant hospital to assess method suitability and limitations. : Residual whole blood samples from patients undergoing immunosuppressant therapy were used for evaluation. Imprecision, linearity, functional sensitivity, method comparisons and lot-to-lot comparisons were assessed. : Total imprecision ranged from 3.3 to 7.1% for CSA, 3.9 to 9.4% for TAC, and 4.6 to 8.2% for SRL. Linearity was verified from 30.0 to 960.9 μg/L for CSA, from 1.1 to 27.1 μg/L for TAC, and from 0.5 to 32.3 µg/L for SRL. The functional sensitivity met the manufacturer's claims and was determined to be <6.5 μg/L for CSA, 1.1 μg/L for TAC, and <0.1 µg/L for SRL (CV≤20%). Deming regression analysis of method comparisons with the ARCHITECT immunoassay yielded slopes of 0.917 (95%CI: 0.885-0.949) and r of 0.985 for CSA, 0.938 (95%CI: 0.895-0.981) and r of 0.974 for TAC, and 0.842 (0.810-1.110) and r of 0.982 for SRL. Deming regression analysis of comparisons with the LC-MS/MS method yielded slopes of 1.331 (95%CI: 1.167-1.496) and r of 0.969 for CSA, 0.924 (95%CI: 0.843-1.005) and r of 0.984 for TAC, and 0.971 (95%CI: 0.913-1.030) and r of 0.993 for SRL. : The cobas e 411 ECLIA for CSA, TAC, and SRL have acceptable precision, linearity, and functional sensitivity. The method comparisons correlated well with the ARCHITECT immunoassay and LC-MS/MS and is fit for therapeutic drug monitoring.
免疫抑制药物的治疗药物监测用于监测药物疗效和毒性，并预防器官移植排斥反应。本研究评估了在一家大型移植医院的罗氏cobas e 411分析仪上，用于检测环孢素（CSA）、他克莫司（TAC）和西罗莫司（SRL）的半自动电化学发光免疫分析法（ECLIA）的分析性能，以评估方法的适用性和局限性。：使用接受免疫抑制治疗患者的剩余全血样本进行评估。评估了精密度、线性、功能灵敏度、方法比较和批次间比较。：CSA的总不精密度范围为3.3%至7.1%，TAC为3.9%至9.4%，SRL为4.6%至8.2%。CSA的线性在30.0至960.9μg/L之间得到验证，TAC在1.1至27.1μg/L之间，SRL在0.5至32.3μg/L之间。功能灵敏度符合制造商的声明，确定为CSA<6.5μg/L，TAC为1.1μg/L，SRL<0.1μg/L（CV≤20%）。与ARCHITECT免疫分析法进行方法比较的Deming回归分析得出，CSA的斜率为0.917（95%CI：0.885-0.949），r为0.985；TAC的斜率为0.938（95%CI：0.895-0.981），r为0.974；SRL的斜率为0.842（0.810-1.110），r为0.982。与LC-MS/MS方法进行比较的Deming回归分析得出，CSA的斜率为1.331（95%CI：1.167-1.496），r为0.969；TAC的斜率为0.924（95%CI：0.843-1.005），r为0.984；SRL的斜率为0.971（95%CI：0.913-1.030），r为0.993。：用于CSA、TAC和SRL检测的cobas e 411 ECLIA具有可接受的精密度、线性和功能灵敏度。该方法比较与ARCHITECT免疫分析法和LC-MS/MS相关性良好，适用于治疗药物监测。
