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

Proficiency evaluation of laboratories for the detection of esterase-3 in the kidneys of laboratory mice

目的通过实验小鼠肾匀浆中酯酶-3项目的检测比对,了解全国实验动物质量检测实验室的水平,促进各实验室加强质控。方法按照CNAS批准的能力验证方案,制备样品并将稳定性和均匀性合格的样品作为能力验证样品,进行随机编号,随作业指导书一起发放给参加单位。在规定时限提交检验报告和原始记录复印件,其结果与样品预检结果完全一致的判为优秀结果;除杂合型判定以外的结果均一致的判定为满意结果,否则判为不满意结果。结果共10个实验室报名参加本次比对试验,其中优秀结果 0个实验室;满意结果的有9个实验室,占参加比对实验室的90.0%;不满意结果 1个实验室,占参加比对实验室的10.0%。结论本次能力验证项目反映了各参与实验室在实验小鼠肾匀浆中酯酶-3的总体检测能力较高,但检测细节及部分实验室技术水平还有待提高。

Objective To investigate the detection capacity of esterase-3（ Es-3） in the laboratory animals monitoring laboratories in China,and to improve the quality management of laboratories. Methods We prepared the test samples according to the criteria of China National Accreditation Service for Conformity Assessment（ CNAS）,all the samples were certificated by homogeneity test and stability test. Then,samples with random numbers and standard operation instruction were distributed to the participant laboratories. The laboratories should submit their reports before the deadline expires.When the results are the same as the standard results,the laboratories will receive excellent remark; when the results are the same as the standard results except the hybridization type,the laboratories will receive satisfactory remark; otherwise,it will receive unsatisfactory remark. If a laboratory did not submit report,the laboratory will also receive unsatisfactory remark. Results Ten laboratories participated in the program,and no laboratory received excellent remark. Nine laboratories（ 90. 0% of enrolled laboratories） had satisfactory results,while one laboratory（ 10. 0% of enrolled laboratories） had unsatisfactory results. Conclusions The nationwide overall detection level of laboratories in Es-3 is relatively high. However,some details should be noticed and several laboratories should improve their detecting ability.