采用基因分型质控品评价荧光PCR法人乳头瘤病毒核酸检测试剂盒

目的: 使用人乳头瘤病毒(HPV)L1基因分型质控品对荧光PCR法人乳头瘤病毒核酸检测试剂盒进行评价。 方法: 以中国药品生物制品检定所体外诊断试剂与培养基室建立的含有30种不同型别HPV基因分型质控品盘为样本,按照各个试剂盒的要求进行检测。 结果: 使用含有30种不同型别HPV基因分型质控品盘为模板进行试剂盒评价时,A试剂检测有23种型别检测结果符合,7种型别不符合,HPV 59型漏检,HPV 53,54,61,66,72,81型有交叉现象。B试剂检测有29种型别检测结果符合,1种型别不符合,HPV 58型漏检。C试剂检测有26种型别检测结果符合,4种型别不符合,HPV 43,66,81,CP 8304型有交叉现象。D试剂有29种型别检测结果符合,1种型别不符合,HPV 68型漏检。对照检测E试剂30种型别的检测结果全部符合。4家公司的试剂基本能正确区分质控品中HPV基因型,但有部分的HPV基因型有漏检现象和交叉反应。对照试剂无漏检交叉现象。 结论: 含有30种不同型别的HPV-L1基因分型质控品能准确地评价4家公司的HPV核酸检测试剂盒(荧光PCR法)和高危型人乳头瘤病毒DNA检测试剂盒(酶切信号放大法)的性能;在HPV核酸检测试剂盒(荧光PCR法)的研发中应在通过质控盘的考核情况下加大临床样本的验证,从而对其产品进行进一步的验证和考核。

Objective: To evaluate the PCR-fluorescent human papillomavirus(HPV) kit by the HPVL1 gene genotyping control materials. Methods： Department of In Vitro Diagnostic Reagents & Medium,National Institute for the Control of Pharmaceutical and Biological Products set up with 30 different type HPV genotyping quality control materials,which were detected as samples,according to the kit instructions. Results： 30 different types with HPV genotyping plate as a template for control materials evaluation kit,A kit test results are 23 species of the correct type and 7 types were wrong which HPV type 59 was missed and HPV types 53,54,61,66,72,81 were cross-reaction.B kit test results are 29 species of the correct type,and 1 type was wrong which HPV type 58 was missed C kit test results are 26 species of the correct type and 4 types were wrong which HPV types 43,66,81,CP8304 were cross-reaction.D kit test results are 29 species of the correct type,and 1 type was wrong which HPV type 68 was missed.E test kits were the correct model test results are 30 species.Four companies kits can correctly distinguish between quality control products in the HPV genotypes,but some of the HPV genotypes have missed the phenomenon,and cross-reaction.Control agent without miss crossover phenomenon. Conclusion： Containing 30 kinds of HPV-L1 genotyping quality control materials can accurately evaluate the four companies HPV DNA test kit(fluorescent PCR method) and the CervistaTM HPV HR test kit(enzyme signal amplification) performance.The kit(fluorescence PCR method) development should be verified by large scale clinical samples after HPV genotyping control materials evaluation,to further validate and assessment their products.