实验大鼠细小病毒H-1株抗体检测能力验证结果评价  

Laboratory Capacity Evaluation Report of Rat Parvovirus H-1 Strain Antibody Detection

作　　者：李晓波[1] 王洪[1] 付瑞[1] 王吉[1] 卫礼[1] 王淑菁[1] 岳秉飞[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2014年第9期990-994,共5页Chinese Pharmaceutical Affairs

基　　金：国家科技支撑计划(编号2013BAK11B01)

摘　　要：目的了解全国实验动物检测相关实验室在大鼠细小病毒H-1株抗体检测项目的技术水平,发现并解决检验中存在的问题,促进各实验室加强质量管理,提高检测水平。方法不限定检测方法,推荐各参加实验室参照国标规定的方法,对统一发放的大鼠血清样品进行细小病毒H-1株的定性检测,结果以阳性或阴性表示,与预期结果均一致判为满意结果,不完全一致或逾期未反馈结果判为不满意。结果来自13个省市自治区的18家单位报名参加本次比对实验,1家单位因故退出,实际参加并发放比对样品共17家单位,其中16家在规定时间反馈了检测结果,1家未在规定时间反馈结果,反馈结果的16个实验室检测结果均为满意,占参加比对实验室的94%,其中13个实验室使用外购试剂盒,14个实验室采用酶联免疫吸附法(ELISA)检测,仅2个实验室对阳性结果进行了复检。结论全国各实验动物检测机构大鼠细小病毒H-1株总体检测能力较高,个别实验室因故未参加或逾期未反馈结果,检测能力有待考察。Objective To investigate the technical level of rat parvovirus H-1 strain detection for experimental animal testing laboratories. To explore and solve the existing problems in H-1 strain detection,so as to promote quality management of laboratories and improve the detection capacity. Methods The detection methods were not restricted.The national standards for laboratory animal were recommended.The aim was to test rat parvovirus H-1 strain of rat serum samples provided and results were expressed as positive or negative. If the test results were consistent with expected results, the laboratory was rated satisfactory.If the results were not entirely consistent or feedback was not got on schedule,the laboratory was rated unsatisfactory.Results 18 laboratories from 13 provinces enrolled in the evaluation and one laboratory withdrew.A total of 1 7 laboratories participated in the evaluation and received the samples, 1 6 of them submitted detection results on time but 1 laboratory did not gave feedback results. The results of the 16 laboratories were all satisfactory, account for 94% of all laboratories.13 of 16 laboratories used outsourcing kit and 14 of them adopted ELISA.Only 2 laboratories rechecked the positive results.Conclusion The H-1 strain detection ability level of animal test laboratories was high. Two laboratories did not attend the evaluation or failed to submit results. Their detection capability remained to be investigated.

关 键 词：大鼠细小病毒 H-1 株 能力验证 

分 类 号：Q953[生物学—动物学]