人乳头瘤病毒核酸(分型)检测试剂(盒)行业标准的验证实验

目的：通过对人乳头瘤病毒（HPV）核酸（分型）检测试剂（盒）行业标准的技术要求进行实验验证，评价了该行业标准的应用性。方法：用人乳头瘤病毒L1基因分型参考品作为统一的标准品，选择不同厂家的人乳头瘤病毒核酸检测试剂盒（PCR-荧光法），对人乳头瘤病毒核酸（分型）检测试剂（盒）行业标准中的准确性、特异性、重复性和检测限等要求进行评价。结果：在准确性、特异性、重复性和检测限等项目中，对人乳头瘤病毒L1基因分型参考品进行检测的实验结果均符合该行业标准的技术要求。结论：制修订的人乳头瘤病毒核酸（分型）检测试剂（盒）行业标准，适用于指导该类产品（PCR-荧光法）的注册检验工作，能够满足我国对该产品试剂盒的监督管理工作需要。

Objective: To evaluate the applicability of the industry standard by validating the technical requirements of the industry standard of human papillomavirus(HPV)nucleic acid(genotyping)detection kit. Methods: The human papillomavirus L1 genotyping reference materials were used as the unified reference standard to test human papillomavirus nucleic acid detection kits from different manufacturers(PCR-fluorescence method).The accuracy,specificity,repeatability and detection limits of industry standard of the human papillomavirus(HPV)nucleic acid(genotyping)detection kit were evaluated. Results: The detection results for human papillomavirus L1 genotyping reference materials by HPV nucleic acid(genotyping)detection kit(PCR-fluorescence method)were in accordance with the technical requirements in industry standard. Conclusion: The formulated and revised industry standard of human papillomavirus(HPV)nucleic acid(genotyping)detection kit can be used to guide the registration test of these products and meet the supervision and management needs.

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