使用Indiko分析仪评估QMS依维莫司测定法：与超高效液相色谱-串联质谱法的比较

Evaluation of QMS everolimus assay using Indiko analyzer: comparison with an ultra-performance liquid chromatography-tandem mass spectrometry method.

作者信息

Buthiau Delphine, Bargnoux Anne-Sophie, Badiou Stéphanie, Sutra Thibault, Dupuy Anne-Marie, Pageaux Georges-Philippe, Mourad Georges, Cristol Jean-Paul

机构信息

*Laboratoire de Biochimie; †Service d'Hépato-gastroentérologie et transplantation; and ‡Service de Néphrologie, Dialyse Péritonéale et Transplantation, CHRU Montpellier, Université Montpellier 1, Montpellier, France.

出版信息

Ther Drug Monit. 2015 Apr;37(2):275-8. doi: 10.1097/FTD.0000000000000133.

DOI:10.1097/FTD.0000000000000133

PMID:25254414

Abstract

BACKGROUND

A new particle-enhanced turbidimetric immunoassay, Quantitative Microsphere System (QMS) everolimus, was evaluated using an Indiko analyzer (Thermo Fisher Scientific).

METHODS

Analytical performances (imprecision, linearity, limit of detection, and limit of quantification) of this new immunoassay were evaluated. The method was compared with an ultra-performance liquid chromatography-tandem mass spectrometry (UPLC/MS/MS) method and with the previously available Innofluor Certican immunoassay on 120 whole-blood samples from 74 transplant recipients. Passing-Bablok regression and Bland-Altman plot were used for method comparisons.

RESULTS

Within- and between-day coefficients of variation were <10% at mean levels of 4.3, 8.2, and 15.9 ng/mL, respectively. This assay could be used at everolimus concentrations between 1.7 and 20 ng/mL. We obtained a Passing-Bablok regression of y = 0.99 × -0.15 (r = 0.95) when comparing with the UPLC/MS/MS method and of y = 0.81 × -0.09 (r = 0.94) when comparing with Innofluor assay. The mean and limits of agreement (mean ± 1.96 SD) of the difference between QMS everolimus and UPLC/MS/MS were -0.13 (from -2.0 to 1.74) ng/mL and were -1.19 (from -3.39 to 1.01) ng/mL between QMS everolimus and Innofluor.

CONCLUSIONS

The QMS everolimus method on Indiko analyzer demonstrated reliable and reproducible performances allowing routine monitoring in transplant patients.

摘要

背景

使用Indiko分析仪（赛默飞世尔科技公司）对一种新型颗粒增强比浊免疫分析法——定量微球系统（QMS）依维莫司进行了评估。

方法

对这种新型免疫分析法的分析性能（不精密度、线性、检测限和定量限）进行了评估。将该方法与超高效液相色谱 - 串联质谱法（UPLC/MS/MS）以及之前可用的Innofluor Certican免疫分析法，在来自74名移植受者的120份全血样本上进行比较。采用Passing - Bablok回归和Bland - Altman图进行方法比较。

结果

日内和日间变异系数在平均水平分别为4.3、8.2和15.9 ng/mL时均<10%。该检测法可用于依维莫司浓度在1.7至20 ng/mL之间的情况。与UPLC/MS/MS方法比较时，我们得到的Passing - Bablok回归方程为y = 0.99x - 0.15（r = 0.95），与Innofluor检测法比较时为y = 0.81x - 0.09（r = 0.94）。QMS依维莫司与UPLC/MS/MS之间差异的均值和一致性界限（均值±1.96 SD）为 - 0.13（范围为 - 2.0至1.74）ng/mL，QMS依维莫司与Innofluor之间为 - 1.19（范围为 - 3.39至1.01）ng/mL。