Precision and accuracy of commercial assays for vancomycin therapeutic drug monitoring: evaluation based on external quality assessment scheme
Precision and accuracy of commercial assays for vancomycin therapeutic drug monitoring: evaluation based on external quality assessment scheme
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DOI：
10.1093/jac/dkaa150
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发表时间：
2020-08-01
影响因子：
5.2
通讯作者：
Cui, Yi-Min
中科院分区：
文献类型：
--
作者：
Chen, Chao-Yang;Li, Meng-Ya;Cui, Yi-Min
背景：万古霉素仍然是治疗革兰氏阳性菌感染的主要药物。准确测定万古霉素血药浓度对适当剂量adjustment. Objective. To评估万古霉素浓度商业测定技术的精密度和准确度，并评估中国实验室万古霉素检测方法的可比性。采用化学发光法、酶免疫法等检测方法，对测定结果进行离散度分析，计算方法组的稳健变异系数（rCV）、相对百分差异（RPD）和满意率。结果：共收集到75家实验室的657份检测结果，其中10家实验室的84份样品。按方法分类的中位rCV、中位RPD和满意率分别为1.85%~ 15.87%、14.75%~ 13.34%和94.59%~ 100.00%。在精密度方面，溶液中微粒动力学相互作用（KIMS）与其他方法之间存在显著差异，在准确度方面，酶倍增免疫测定技术（EMIT），荧光偏振免疫测定（FPIA）与其他技术之间存在显著差异。结论：尽管本研究中几乎所有的检测方法都达到了可接受的性能，但仍然观察到了明显的不一致性。中国实验室更有可能低估万古霉素浓度。因此，认识到方法之间的不一致性并定期参与万古霉素EQAS至关重要。
Background: Vancomycin remains a mainstay of the treatment of Gram-positive bacterial infections. It is crucial to accurately determine vancomycin serum concentration for adequate dose adjustment.Objectives: To evaluate the precision and accuracy of commercial assay techniques for vancomycin concentration and to assess the comparability of vancomycin detection methods in Chinese laboratories.Methods: Human serum samples spiked with known concentrations of vancomycin were provided to laboratories participating in the external quality assessment scheme (EQAS). Assay methods included chemiluminescence, enzyme immunoassay (EIA) and so on. The dispersion of the measurements was analysed and the robust coefficient of variation (rCV), relative percentage difference (RPD) and satisfactory rate for method groups were calculated. Moreover, performance of the Chinese laboratories was assessed.Results: A total of 657 results from 75 laboratories were collected, including 84 samples from 10 Chinese laboratories. The median rCV, median RPD and satisfactory rates classified by methods ranged from 1.85% to 15.87%, #14.75% to 13.34% and 94.59% to 100.00%, respectively. Significant differences were seen in precision, between kinetic interaction of microparticles in solution (KIMS) and other methods, and in accuracy, between enzyme-multiplied immunoassay technique (EMIT), fluorescence polarization immunoassay (FPIA) and other techniques. Vancomycin detection in China mainly depended on the chemiluminescence and EMIT methods, which tended to result in lowermeasurements.Conclusions: Although almost all assays in this study achieved an acceptable performance for vancomycin serumconcentration monitoring, obvious inconsistencies between methods were still observed. Chinese laboratories were more likely to underestimate vancomycin concentrations. Thus, recognizing inconsistencies between methods and regular participation in vancomycin EQAS are essential.