甲型H1N1流感病毒核酸检测试剂盒行业标准的验证

目的规范和提高甲型H1N1流感病毒核酸检测试剂盒（荧光PCR法）的质量,提出本行业标准并加以验证。方法使用市场上4家试剂盒对本标准的外观、阳性和阴性参考品符合率、最低检测限、重复性和稳定性等项目进行试验验证。结果除试剂盒D（北京金豪制药股份有限公司生产）外观和重复性项目不符合外,其他试剂盒的验证结果均符合标准的规定。加速稳定性试验结果显示,试剂盒A（中山大学达安基因股份有限公司生产）检测重复性参考品R2和25℃下放置2d条件下出现较多不合格结果,其他产品均符合标准规定。结论多数试剂盒的验证结果符合行业标准的要求,说明本标准整体具有合理性。本标准的建立有利于进一步规范和提高该类产品的质量,为将来核酸检测试剂盒加速稳定性条件的探索工作提供了依据。

Validation of reference kit for nucleic acid detection of influenza A virus H1N1

Objective To standardize and improve the quality of Influenza A virus RNA detection kit（fluorescent PCR）.Methods Four registered Influenza A virus RNA detection kits（fluorescent PCR）were used for the validation of positive/negative reference samples to evaluate the limit of detection,precision and stability.Results Except the kit produced by KINGHAWK CO.,LTD.,all other kits were well qualified according to the requirements of the proposed quality standard.For accelerated stability,only the precision of the kit from DAAN CO.,LTD.did not meet the requirement of the standard when reference material R2 was tested.Conclusions Most kits tested meet the requirement of standardization.