实验动物科学 ›› 2017, Vol. 34 ›› Issue (01): 1-6.

• 研究 论著 •    下一篇

实验大鼠仙台病毒抗体检测能力验证结果评价

  

  1. ( 中国食品药品检定研究院,北京100050)
  • 出版日期:2017-02-28 发布日期:2017-06-08
  • 基金资助:

    <p>基金项目: 国家科技支撑计划( No. 2015BAI07B02)</p>

Laboratory Proficiency Testing for Rat Sendai Virus Antibody Detection

  • Online:2017-02-28 Published:2017-06-08

摘要: 摘要: 目的了解全国实验动物检测相关实验室在大鼠仙台病毒抗体检测项目上的技术水平,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。方法制备标准实验大鼠血清样品,经过标定后分装,按照CNAS 的要求进行均一性和稳定性验证,标定好的样品随机编号并随机发放给各参加实验室,每个实验室3 个样本,在规定时间内反馈结果,结果以阳性或阴性表示,与预期结果均一致者判为满意结果,不完全一致或逾期未反馈结果者判为不满意。结果来自18 个省市自治区的28 家单位报名参加本次比对实验,均在规定时间反馈了结果,其中25 家单位获得满意结果,占参加比对实验室的89. 3%; 结果不满意的3 家单位,其中1 家有1 个样品与预期结果不符,另外2 家均有2 个样品与结果不符。28 家单位中有27 家采用酶联免疫吸附法( ELISA) 检测,另外1 家用免疫荧光法( IFA) 检测。反馈的原始记录总体真实可信,个别参加单位存在检测试剂来源不清、操作过程不详及阳性结果未进行复检等问题。结论各实验动物检测机构大鼠仙台病毒总体检测能力较高,本次能力验证计划的实施能够反映实验室的检测水平。

关键词: <, p>, 大鼠仙台病毒, 能力验证, 酶联免疫吸附试验, 免疫荧光实验<, /p>

Abstract: Abstract: Objective To investigate the technical level of rat Sendai virus antibody detection for lab animal testing laboratories. To explore and solve the existing problems in Sendai virus detection,so as to promote quality management of laboratories and improve the detection level. Method To prepare rat serum samples after calibration and test their stability and homogeneity according to CNAS. The samples were numbered randomly and distributed to the participating laboratories. Each laboratory received three samples and must send results to us in a specified time. The results were expressed as positive or negative. If the test results were consistent with expected results,the laboratory was judged satisfactory. If the results were not entirely consistent or feedback was not got on schedule,the laboratory was judged unsatisfactory. Result Twenty-eight laboratories from 18 provinces enrolled in the program and sent the results in a specified time. The results of 25 laboratories were all satisfactory,which were 89. 3% of all laboratories. 3 laboratories were not satisfactory,one of which has one sample which result did not match and the other 2 laboratories have 2 samples which did not match. 27 of 28 laboratories adopted ELISA and one lab used IFA. The original records were authentic but individual labortories have some problems,such as reagent is not clear,operation process is not detailed and positive results were not retested. Conclusion The Sendai virus detection ability level of animal test laboratories is high. The implementation of proficiency testing can reflect the detection level of laboratories.

Key words: <p>Rat sendai virus, proficiency testing, ELISA, Immunofluorescence assay</p>

中图分类号: