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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。
OBJECTIVE To understand the technical level of testing laboratories of Sendai virus in rats in the laboratory of detection of experimental animals in the whole country, discover and solve the problems existing in the tests, and promote the laboratories to strengthen quality control and improve the detection level. Methods The standard experimental rat serum samples were prepared, calibrated and packaged. The samples were verified according to the requirements of CNAS. The calibrated samples were randomly assigned to three participating laboratories and three laboratories. Feedback within the specified time, the results were positive or negative, as expected results were agreed to be satisfied with the results, not entirely consistent or overdue feedback was not satisfied with the results. Results 28 units from 18 provinces, autonomous regions and municipalities were enrolled in this comparison experiment, all of which returned the results within the stipulated time. Among them, 25 units obtained satisfactory results, accounting for 89.3% of the participating laboratories; 3 Home units, of which 1 had a sample does not match the expected results, the other two have 2 samples and the results do not match. Twenty-seven of the 28 units were detected by enzyme-linked immunosorbent assay (ELISA) and one was detected by immunofluorescence (IFA). Feedback the original record of the overall credible, individual participating units there is unclear sources of detection reagents, the operation is not known and the positive results were not re-examination and other issues. Conclusions The detection capacity of Sendai virus in rats of all kinds of experimental animals is high. The implementation of this proficiency testing program can reflect the level of laboratory testing.