实验小鼠细小病毒(MMV)抗体的实验室检测能力验证结果评价

目的通过实验小鼠细小病毒(Murine minute virus,MMV)抗体检测能力验证实施计划,了解我国实验动物检测机构的检验能力,促进实验动物质量检测水平的提高。方法按照CNAS批准的能力验证方案,血清经过标定后,经过稳定性和均匀性等检验合格,作为能力验证样本。对血清样本采用随机编号形式发放给能力验证参加单位,并附作业指导书。本次能力验证为定性检测,检测方法采用ELISA方法。要求参加单位在规定时限提交检验报告和原始记录复印件,满意结果为样品的检测结果与预检结果一致,不满意结果为样品检测结果与预检结果不一致或参加单位未反馈结果。结果样本血清均匀性试验和稳定性试验结果显示,样本均符合能力验证样本均匀性和稳定性要求。本次能力验证共有19个省市的33个实验动物检测机构报名参加。33个检测机构均提交了满意结果,满意度为100%。结论实施此次能力验证计划能够反映我国实验动物检测实验室的检测能力和水平,我国实验动物质量检测机构对实验小鼠细小病毒(MMV)抗体检测的能力较高。

The Evaluation of Proficiency Testing for Minute Virus of Mice Antibody in Laboratory Mice Detection

Objective Through the capability verification of Minute virus of mice (MMV ) antibody in laboratory mice detection, to investigate the capacity of experimental animal quality control laboratories, so as to promote the improvement of laboratory animal quality testing level. Method According to the capability verification scheme approved by CNAS, the serums were calibrated, and passed the stability and homogeneity test. Then the serums were used as the proficiency testing samples. The samples were randomly numbered, and then sent to the units participating in the capacity verification, and attach the work instruction. This capability verification was a qualitative test, and the test method was ELISA. The participating units are required to submit the test report and copy of original record within the prescribed time limit, The satisfactory result is that the test result of the sample is consistent with the pre-test result, the unsatisfactory result is that the sample test result is inconsistent with the pre- test result or the participating units did not feedback the result. The participants must submit the test reports and original records in time. The feedback result were judged by the rate of concordance with the anticipated result. Result The result of uniformity test and stability test of samples all met the requirements of capability verification for samples. There were 33 animal testing institutions from 19 provinces and cities took part in this capability verification. The results ubmitted by 33 testing institutions are all satisfactory, and the satisfaction of this capability verification is 100%. Conclusion It can be reflected the testing ability and level of China ‘s testing laboratories for the quality control of laboratory animal by this capability verification plan , and the ability for detection of minute virus of mice antibody in laboratory mice was high .