2011—2017年实验动物遗传质量评价能力验证结果分析
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摘要
目的通过分析2011—2017年实验动物遗传质量评价能力验证计划的结果,旨在发现各实验室在实验动物遗传质量评价方面存在的问题,了解我国实验动物质量控制的发展趋势。方法按照ISO/IEC17043实施6次能力验证计划,统计各实验室检测能力的变化,对所有参加实验室的能力给予评价。结果全国各实验室累计57次参加了2011—2017年的6次能力验证活动,整体满意率为82.5%。6次能力验证活动的满意率分别为60.0%、80.0%、90.0%、80.0%、90.9%和81.8%,个别实验室出现多次不满意结果。结论通过开展能力验证活动,全国实验动物检测实验室的检测能力得到提升,为我国实验动物质量检测评价体系的建设提供了重要支撑。
Objective Proficiency testing(PT) during 2011—2017 were evaluated in order to find problems of laboratories and to understand the change of the testing capacity of laboratories. Method According to ISO/IEC 17043, six PT were carried on and the change of the testing capacity was analyzed. The capacity of all the laboratories was evaluated. Result Totally 57 laboratories participated in the six PT. The average satisfaction rate was 82.5%. The satisfaction rate of six PT was 60.0%, 80.0%, 90.0%, 80.0%, 90.9% and 81.8%, respectively. Conclusion PT can help laboratories to increase their testing capacity and strengthen the system construction of laboratory animals' quality monitoring.
Objective Proficiency testing(PT) during 2011—2017 were evaluated in order to find problems of laboratories and to understand the change of the testing capacity of laboratories. Method According to ISO/IEC 17043, six PT were carried on and the change of the testing capacity was analyzed. The capacity of all the laboratories was evaluated. Result Totally 57 laboratories participated in the six PT. The average satisfaction rate was 82.5%. The satisfaction rate of six PT was 60.0%, 80.0%, 90.0%, 80.0%, 90.9% and 81.8%, respectively. Conclusion PT can help laboratories to increase their testing capacity and strengthen the system construction of laboratory animals' quality monitoring.
引文
[1] 贺争鸣,李根平.建立和完善全国实验动物质量抽查检验的新机制[J].实验动物科学,2011,28(4):43-45.
[2] ISO/IEC 17025:2005检测和校准实验室能力认可准则[S].2005.
[3] 毛歆,项新华,肖镜.2013年食品药品系统实验室能力验证结果分析[J].中国药事,2015,29(11):1145-1150.
[4] 世界标准化组织.ISO/IEC 17043:2010 Conformity Assessment-General Requirements for Proficiency Testing[M].北京:中国计量出版社,2012.
[5] 王洪,魏杰,李芳芳,等.实验动物质检机构碱性磷酸酶-1测定能力验证评价[J].中国药事,2014,28(12):1339-1341.
[6] 王洪,魏杰,于鹏丽,实验小鼠肾匀浆中苹果酸酶-1和异柠檬酸脱氢酶-1实验室检测能力验证结果评价[J],中国实验动物学报,2016,24(2):199-203.
[7] 王洪,贺争鸣,魏杰,2013—2015年实验动物质量检测机构实验室能力验证结果分析[J],实验动物科学,2016,33(1):45-48.
[8] 魏杰,王洪,巩薇,等.实验小鼠肾匀浆中酯酶-3的实验室测定能力验证结果评价[J],中国实验动物学报,2016,24(2):204-207.
[9] 魏杰,王洪,李芳芳,等.实验室能力验证用酯酶-3标准样品的均匀性和稳定性研究[J],中国药事,2015,29(3):277-280.
[10] 魏杰,王洪,巩薇,等.实验小鼠血清中酯酶-1的检测能力验证结果评价[J].中国比较医学杂志,2017,27(3):63-67.
[11] ISO/IEC 17011:2004合格评定认可机构通用要求[S].2004.
[2] ISO/IEC 17025:2005检测和校准实验室能力认可准则[S].2005.
[3] 毛歆,项新华,肖镜.2013年食品药品系统实验室能力验证结果分析[J].中国药事,2015,29(11):1145-1150.
[4] 世界标准化组织.ISO/IEC 17043:2010 Conformity Assessment-General Requirements for Proficiency Testing[M].北京:中国计量出版社,2012.
[5] 王洪,魏杰,李芳芳,等.实验动物质检机构碱性磷酸酶-1测定能力验证评价[J].中国药事,2014,28(12):1339-1341.
[6] 王洪,魏杰,于鹏丽,实验小鼠肾匀浆中苹果酸酶-1和异柠檬酸脱氢酶-1实验室检测能力验证结果评价[J],中国实验动物学报,2016,24(2):199-203.
[7] 王洪,贺争鸣,魏杰,2013—2015年实验动物质量检测机构实验室能力验证结果分析[J],实验动物科学,2016,33(1):45-48.
[8] 魏杰,王洪,巩薇,等.实验小鼠肾匀浆中酯酶-3的实验室测定能力验证结果评价[J],中国实验动物学报,2016,24(2):204-207.
[9] 魏杰,王洪,李芳芳,等.实验室能力验证用酯酶-3标准样品的均匀性和稳定性研究[J],中国药事,2015,29(3):277-280.
[10] 魏杰,王洪,巩薇,等.实验小鼠血清中酯酶-1的检测能力验证结果评价[J].中国比较医学杂志,2017,27(3):63-67.
[11] ISO/IEC 17011:2004合格评定认可机构通用要求[S].2004.