评估用于测量血清中氨基糖苷类药物的检测方法：基于外部质量评估的准确性和精密度比较。

Evaluation of Assays to Measure Aminoglycosides in Serum: Comparison of Accuracy and Precision Based on External Quality Assessment.

机构信息

Department of Pharmacy, Peking University First Hospital; and.

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing, People's Republic of China.

出版信息

Ther Drug Monit. 2020 Oct;42(5):710-715. doi: 10.1097/FTD.0000000000000752.

DOI:10.1097/FTD.0000000000000752

PMID:32118804

Abstract

BACKGROUND

Aminoglycosides require highly accurate therapeutic drug monitoring owing to their narrow therapeutic windows and toxic side effects. Therapeutic drug monitoring varies in different laboratories, and this difference is mainly due to the use of different analytical techniques. This study aimed to compare the accuracy and precision of immunoassays for the measurement of gentamicin, tobramycin, and amikacin in serum.

METHODS

Human plasma samples were spiked with known concentrations of amikacin, gentamicin, and tobramycin and dispatched to laboratories worldwide. The percentage deviation and coefficient of variation were calculated to compare the accuracy and precision among immunoassays and among antibiotics.

RESULTS

We analyzed 273, 534, and 207 amikacin, gentamicin, and tobramycin measurement results, obtained satisfactory rates of 83.9%, 86.3%, and 93.7%, and coefficients of variation ranging from 1.1% to 15.6%, 2.9% to 25.2%, and 1.8% to 27.0%, respectively. The percentage deviation ranged from -7.5% to 6.6%, -20.8% to 18.7%, and -33.2% to 41.5% for amikacin, gentamicin, and tobramycin, respectively. Significant differences were observed in accuracy and precision among assays for all antibiotics.

CONCLUSIONS

This study demonstrated high variations in results obtained from antibiotic assays conducted at different laboratories worldwide.

摘要

背景

由于氨基糖苷类药物的治疗窗较窄且具有毒性副作用，因此需要高度准确的治疗药物监测。治疗药物监测在不同的实验室中有所差异，这种差异主要是由于使用了不同的分析技术。本研究旨在比较免疫测定法在测量血清中庆大霉素、妥布霉素和阿米卡星的准确性和精密度。

方法

将已知浓度的阿米卡星、庆大霉素和妥布霉素添加到人血浆样本中，并分发给世界各地的实验室。计算百分比偏差和变异系数，以比较免疫测定法之间以及抗生素之间的准确性和精密度。

结果

我们分析了 273、534 和 207 个阿米卡星、庆大霉素和妥布霉素的测量结果，获得了 83.9%、86.3%和 93.7%的满意率，变异系数分别为 1.1%至 15.6%、2.9%至 25.2%和 1.8%至 27.0%。阿米卡星、庆大霉素和妥布霉素的百分比偏差分别为-7.5%至 6.6%、-20.8%至 18.7%和-33.2%至 41.5%。所有抗生素的测定方法在准确性和精密度方面均存在显著差异。