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急性肾衰竭患者的万古霉素检测性能

Vancomycin assay performance in patients with acute renal failure.

作者信息

Trujillo T N, Sowinski K M, Venezia R A, Scott M K, Mueller B A

机构信息

Department of Pharmacy, Clarian Health Partners, Inc., Indianapolis, Indiana, USA.

出版信息

Intensive Care Med. 1999 Nov;25(11):1291-6. doi: 10.1007/s001340051060.

Abstract

OBJECTIVE

Fluorescence polarization immunoassays (FPIA) have been reported to overestimate vancomycin serum concentrations compared to high-performance liquid chromatography (HPLC) or enzyme multiplied immunoassay technique (EMIT) in patients with chronic renal disease. The assay manufacturer has modified the FPIA to remedy this overestimation. The purpose of this study was to compare the assay performance of two FPIAs to EMIT in acute renal failure patients receiving vancomycin and continuous venovenous hemofiltration.

DESIGN

Open-label trial.

SETTING

Intensive care unit in a university affiliated hospital.

PATIENTS AND PARTICIPANTS

15 serum and ultrafiltrate samples were obtained from 14 critically ill patients (mean +/- SD; 57 +/- 12 years; 8 males/6 females).

MEASUREMENTS AND RESULTS

Vancomycin concentrations were determined by a polyclonal FPIA (pFPIA) performed on the TDx system, a monoclonal FPIA (mFPIA) performed on the AxSYM system and EMIT. The coefficient of variation for all assays was < 5%. The mean difference +/- SDd between mFPIA vs EMIT and pFPIA vs EMIT assays in serum were: -0.08 +/- 1.55 and 1.24 +/- 2.11 mg/l, respectively. The limits of agreement between the mFPIA vs EMIT and pFPIA vs EMIT assays in serum were: -3.18 to 3.03 and -2.99 to 5.46 mg/l, respectively.

CONCLUSIONS

Our data demonstrate that the manufacturer's changes to the pFPIA have reduced overestimation. The mFPIA appears to be an acceptable assay for measuring vancomycin serum concentrations in acute renal failure patients and does not significantly overestimate these concentrations.

摘要

目的

据报道,与高效液相色谱法(HPLC)或酶放大免疫分析技术(EMIT)相比,荧光偏振免疫分析法(FPIA)在慢性肾病患者中会高估万古霉素血清浓度。该检测方法的制造商已对FPIA进行了改进以纠正这种高估情况。本研究的目的是比较两种FPIA与EMIT在接受万古霉素治疗且进行持续静静脉血液滤过的急性肾衰竭患者中的检测性能。

设计

开放标签试验。

地点

大学附属医院的重症监护病房。

患者和参与者

从14例危重症患者(平均±标准差;57±12岁;8例男性/6例女性)中获取了15份血清和超滤液样本。

测量和结果

万古霉素浓度通过在TDx系统上进行的多克隆FPIA(pFPIA)、在AxSYM系统上进行的单克隆FPIA(mFPIA)以及EMIT来测定。所有检测方法的变异系数均<5%。血清中mFPIA与EMIT以及pFPIA与EMIT检测之间的平均差值±标准差分别为:-0.08±1.55和1.24±2.11mg/L。血清中mFPIA与EMIT以及pFPIA与EMIT检测之间的一致性界限分别为:-3.18至3.03和-2.99至5.46mg/L。

结论

我们的数据表明,制造商对pFPIA所做的改变减少了高估情况。mFPIA似乎是一种可接受的用于测量急性肾衰竭患者万古霉素血清浓度的检测方法,且不会显著高估这些浓度。

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