QMS依维莫司检测法在奥多Vitros 5,1 FS融合分析仪上的分析性能：测定实体器官移植受者的依维莫司谷浓度

Analytical performance of QMS everolimus assay on ortho Vitros 5,1 FS fusion analyzer: measuring everolimus trough levels for solid organ transplant recipients.

作者信息

Shu Irene, Wright Angela M, Chandler Wayne L, Bernard David W, Wang Ping

机构信息

Department of Pathology and Genomic Medicine, The Methodist Hospital, Houston, TX.

出版信息

Ther Drug Monit. 2014 Apr;36(2):264-8. doi: 10.1097/FTD.0b013e3182a3b3f6.

DOI:10.1097/FTD.0b013e3182a3b3f6

PMID:24232125

Abstract

BACKGROUND

Everolimus has recently been approved by Food and Drug Administration for graft maintenance in liver transplant recipients. This drug has a narrow therapeutic index and benefits from close blood level monitoring. Currently, in the United States, the Thermo Fisher Scientific Quantitative Microsphere System (QMS) Everolimus Immunoassay is the only Food and Drug Administration-cleared immunoassay for monitoring everolimus in renal transplant recipients. However, studies on this assay adapted to the Ortho Vitros 5,1 FS chemistry analyzer have not been published, and data of this assay applied to monitoring drug levels in liver transplant recipients are limited. Here, the authors evaluated and validated the QMS everolimus assay on the Vitros analyzer and its application to supporting the immunosuppressant management of mainly liver transplant recipients.

METHODS

The analysis was performed according to the QMS assay package insert. The method was compared with a liquid chromatography-tandem mass spectrometry method from a reference laboratory using a total of 34 samples from 1 double lung and liver, 8 liver, and 3 kidney recipients. The method comparison was assessed by Deming regression. Proficiency test materials issued by Everolimus TDM Proficiency Support Program were tested and compared with the peer group results of using the QMS kits.

RESULTS

The assay was linear in the range of 0.75-20.0 ng/mL. Limit of detection was 0.70 ng/mL and lower limit of quantitation was 0.75 ng/mL. Within-day and between-day (20 days) coefficients of variation were between 3.1% and 16.5% at mean levels of 5.3, 12.0, and 17.2 ng/mL, respectively. We obtained a Deming regression of y = 1.271 - 0.666 (r = 0.880) when comparing with the liquid chromatography-tandem mass spectrometry method.

CONCLUSIONS

The authors concluded that the analytical performance of the QMS everolimus immunoassay by the Vitros 5,1 FS analyzer was satisfactory for monitoring drug levels of solid organ transplant patients.

摘要

背景

依维莫司最近已获美国食品药品监督管理局批准用于肝移植受者的移植物维持治疗。该药物治疗指数狭窄，需要密切监测血药浓度。目前在美国，赛默飞世尔科技定量微球系统（QMS）依维莫司免疫测定法是唯一经美国食品药品监督管理局批准用于监测肾移植受者依维莫司血药浓度的免疫测定法。然而，关于该测定法适配于奥森多Vitros 5,1 FS化学分析仪的研究尚未发表，且该测定法应用于监测肝移植受者药物浓度的数据有限。在此，作者评估并验证了在Vitros分析仪上的QMS依维莫司测定法及其在支持主要肝移植受者免疫抑制剂管理方面的应用。

方法

分析按照QMS测定法试剂盒说明书进行。使用来自1例双肺和肝移植受者、8例肝移植受者和3例肾移植受者的共34份样本，将该方法与参考实验室的液相色谱 - 串联质谱法进行比较。通过Deming回归评估方法比较结果。对依维莫司治疗药物监测能力验证支持计划发放的能力验证材料进行检测，并与使用QMS试剂盒的同行组结果进行比较。

结果

该测定法在0.75 - 20.0 ng/mL范围内呈线性。检测限为0.70 ng/mL，定量下限为0.75 ng/mL。在平均水平分别为5.3、12.0和17.2 ng/mL时，日内和日间（20天）变异系数分别在3.1%至16.5%之间。与液相色谱 - 串联质谱法比较时，我们得到的Deming回归方程为y = 1.271x - 0.666（r = 0.880）。