2013年度人乳头瘤病毒（HPV）核酸检测试剂盒抽验质量分析

目的:用4种方法对17家企业17批次的人乳头瘤病毒（HPV）核酸检测试剂盒进行评价性抽验结果分析，考察我国该类试剂的质量现状。方法：依据企业产品注册标准，对准确性、特异性、检测限3个项目进行检验，同时以国家参考品为样本，依据国家参考品说明书，进行探索研究。结果：本次监督抽验中，17批次试剂的准确性、特异性、检测限均符合产品注册标准的要求。在探索研究中发现，仅有10批次试剂符合特异性项目的要求，低危型别参考品交叉反应率最高为32.3%，高危型别参考品交叉反应率最高为10.0%。结论：各企业产品注册标准存在差异，在统一使用国家参考品检验时，存在交叉反应，特异性项目合格率较低，建议企业不断完善产品，将来统一使用国家参考品进行检测。

Objective: To evaluate the quality status of human popiliomavirus(HPV) reagent through testing 17 batches of HPV DNA detection kits from 17 companies.Methods: The accuracy,specificity and detection limit were verified in accordance with industry standards,taking the national reference material as the specimen for the exploratory study.Results: In this sample testing,the accuracy,specificity and detection limit of 17 batches of reagents all met industry standards, with a pass rate of 100%.However,in the exploratory study where the national reference was used,only 10 batches of reagents met the requirement for specificity.The cross-reactivity rate was up to 32.3% for the low-risk reference,and was up to 10.0% for the high-risk reference.Conclusion: There were differences between each industry standard.When testing with the unified national reference,the cross reactivity emerged,and the pass rate for specificity was low.It is recommended that companies continue to improve products,and adopt the national reference for future use of testing.

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