摘要
目的:通过实验小鼠肾匀浆中肽酶-3检测能力验证计划,了解实验动物检测机构检验能力,提高实验动物质量检测水平。方法:按照CNAS批准的能力验证方案,通过样品制备,经过稳定性和均匀性检验合格,作为能力验证样品。采用随机编号,发样给参加单位,并附作业指导书。在规定时限提交检验报告和原始记录复印件,其结果与样品标准结果一致的判为满意结果,不一致或未能提交结果的判为不满意结果。结果:共有11个实验室参加本次能力验证项目,其中提交满意结果的实验室有9个,占总参加机构的81.8%,不满意的实验室有2个,占18.2%。结论:实验动物质量检测机构在实验小鼠肾匀浆中肽酶-3的检测能力较高,实施能力验证计划能够反映实验室的检测水平。
Objective: To understand the capacity of laboratory animals testing institutes of China in order to improve the quality of experimental animals testing through the proficiency test(PT) of determination of the peptidase-3(Pep-3) in experimental mouse kidney homogenate. Methods: Samples were prepared and passed stability test and homogeneity test and were used as proficiency test samples according to the PT protocol approved by CNAS. The samples were numbered at random and sent to participating laboratories together with instructions. The participating laboratories should submit the test report and copies of the original records within the time limit. The laboratory results were considered to be satisfactory if the results were the same as the standard results, whereas the laboratory results were considered to be unsatisfactory if the results were not the same as the standard results or not submitted. Results: A total of 11 laboratories participated in this PT program. 9 laboratories presented satisfactory experiment results, accounting for 81.8%. 2 laboratories presented unsatisfactory results, accounting for 18.2%. Conclusion: The overall capacity of laboratory animals testing institutes in determination of the Pep-3 in experimental mouse kidney homogenate was relatively high. The PT program could reflect the capacity of laboratories.
作者
王洪
魏杰
王淑菁
巩薇
岳秉飞
Wang Hong, Wei Jie, Wang Shujing, Gong Wei, Yue Bingfei(National Institutes for Food and Drug Control, Beijing 100050, Chin)
出处
《中国药事》
CAS
2018年第3期329-334,共6页
Chinese Pharmaceutical Affairs
关键词
能力验证
实验动物
肽酶-3
proficiency test
experimental animal
peptidase-3