CEDIA 检测法与 HPLC-UV 法相比，检测麦考酚酸浓度时存在正偏倚：CEDIA 检测法是否适用于麦考酚酸的治疗药物监测？

Positive bias in mycophenolic acid concentrations determined by the CEDIA assay compared to HPLC-UV method: is CEDIA assay suitable for therapeutic drug monitoring of mycophenolic acid?

机构信息

Department of Pathology, University of Texas-Houston Medical School and Laboratory Services Memorial-Hermann Hospital at Texas Medical Center, Houston, TX, USA.

出版信息

J Clin Lab Anal. 2013 Jan;27(1):77-80. doi: 10.1002/jcla.21565.

DOI:10.1002/jcla.21565

PMID:23325745

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6807549/

Abstract

BACKGROUND

Both immunoassays and chromatographic methods are available for therapeutic drug monitoring of mycophenolic acid (MPA), an immunosuppressant. We studied the suitability of cloned enzyme donor immunoassay (CEDIA) assay for routine monitoring of MPA by comparing values obtained by the CEDIA assay with corresponding values obtained by using a high-performance liquid chromatography combined with ultraviolet detection (HPLC-UV) method.

METHODS

We compared MPA concentrations obtained by a reference HPLC-UV method and CEDIA assay on Hitachi 917 analyzer (Roche Diagnostics, Indianapolis, IN) using 60 patient specimens (18 liver transplant recipient and 42 kidney transplant recipients).

RESULTS

When MPA concentrations in all 60 transplant recipients obtained by the HPLC-UV (x-axis) method were compared with corresponding values obtained by the CEDIA method (y-axis), the following regression equation was obtained: y = 1.1558x + 0.2876 (r = 0.97). Interestingly, much lower bias was observed in 42 renal transplant recipients as revealed by the following regression equation; y = 1.1181x + 0.2745 (r = 0.98). However, more significant positive bias was observed in 18 liver transplant recipients as following regression equation as observed: y = 1.3337x + 0.1493 (r = 0.94).

CONCLUSIONS

We conclude that MPA concentrations determined by the CEDIA assay showed significant positive bias compared to HPLC-UV method. Therefore, caution must be exercised in interpreting therapeutic drug monitoring result of MPA if CEDIA assay is used.

摘要

背景

免疫测定法和色谱法均可用于霉酚酸（MPA）的治疗药物监测，MPA 是一种免疫抑制剂。我们通过比较克隆酶供体免疫测定（CEDIA）法和高效液相色谱法结合紫外检测（HPLC-UV）法获得的结果，研究了 CEDIA 法用于 MPA 常规监测的适用性。

方法

我们使用 60 份患者标本（18 例肝移植受者和 42 例肾移植受者），比较了日立 917 分析仪（罗氏诊断公司，印第安纳波利斯，IN）上参考 HPLC-UV 方法和 CEDIA 法获得的 MPA 浓度。

结果

当通过 HPLC-UV（x 轴）方法获得的所有 60 例移植受者的 MPA 浓度与 CEDIA 方法（y 轴）获得的相应值进行比较时，得到以下回归方程：y=1.1558x+0.2876（r=0.97）。有趣的是，通过以下回归方程观察到在 42 例肾移植受者中观察到的偏差小得多：y=1.1181x+0.2745（r=0.98）。然而，在 18 例肝移植受者中观察到的回归方程显示出更显著的正偏差：y=1.3337x+0.1493（r=0.94）。