人乳头瘤病毒全基因组基因分型国家参考品在评价人乳头瘤病毒核酸检测试剂中的应用

目的：使用人乳头瘤病毒全基因组基因分型国家参考品对人乳头瘤病毒核酸（分型）检测试剂盒进行评价。方法：采用建立的人乳头瘤病毒 全基因组基因分型国家参考品，以参考盘包含的20种不同型别的人乳头瘤病毒全基因组重组质粒DNA和5份阴性参考品为样本，按照各个试剂盒要求进行检测。结果：检测人乳头瘤病毒全基因组基因分型国家参考品，试剂A、C、D检测结果全部符合，试剂B在特异性检测试验时HPV 31、59型有交叉，试剂E在特异性检测时HPV 6、26、66、67、82型有交叉。结论：包含20种不同型别的人乳头瘤病毒全基因组基因分型国家参考品能可靠评价人乳头瘤病毒核酸（分型）检测试剂盒。

Objective: To evaluate human papillomavirus nucleic acid detection kits by using human papillomavirus complete genome genotyping reference materials. Methods: The HPV complete genome genotyping reference materials included 20 different genotypes and 5 negative samples;the reference materials were used as samples for testing by human papillomavirus nucleic acid detection kit according to the instruction. Results: The results of the reference materials detected were as follow:The kit A,C and D matched the requirements;there was cross-reactivity for two types (HPV 31 and HPV 59) in the test of kit B and cross-reactivity for 5 types (HPV 6,26,66,67,82) for kit E. Conclusion: The reference materials are suitable and reliable for the quality evaluation of human papillomavirus nucleic acid detection kits.

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