抗生素HPLC含量测定能力验证研究

The proficiency testing for the determination of antibiotics by HPLC-based assays

目的了解和评价参加实验室采用HPLC法进行抗生素含量测定的能力。方法按照CNAS-GL03:2018《能力验证样品均匀性和稳定性评价指南》规定的方法进行均匀性检验和稳定性检验。以z比分数作为统计量对参加实验室的检测结果进行评价,算法为稳健统计方法,选择全部参加实验室上报结果的中位值作为指定值、标准化四分位距作为能力评定标准差。结果及结论能力验证样品的均匀性和稳定性均符合要求。在142家参加实验室中,123家实验室的检测结果评定为“满意”,满意率为86.6%;14家实验室的检测结果评定为“可疑”,可疑率为9.9%;5家实验室的检测结果评定为“不满意”,不满意率为3.5%。

Objective To find out and evaluate the proficiency of the participating laboratories for determining the antibiotics by HPLC-based assays.Methods The uniformity test and stability test were carried out in accordance with the method specified in CNAS-GL03:2018 Guidelines for the Evaluation of Uniformity and Stability of Capability Verification Samples.z-scores were used as the statistic to evaluate the test results of the participating laboratories.The algorithm is a robust statistical method,with the median value and NIQR of all reported results by participating laboratories as the assigned value and the standard deviation for proficiency assessment,respectively.Results and conclusion The uniformity and stability of the proficiency test samples both met the requirements.Among the 142 participating laboratories,the results of 123 laboratories were rated as“satisfactory”with a satisfaction rate of 86.6%;the results of 14 laboratories were rated as“suspicious”with a suspicious rate of 9.9%and 5 laboratories were rated as“unsatisfactory”with a dissatisfaction rate of 3.5%.