Upgrading of national reference materials for the L1 region of Human Papillomavirus genotyping
Objective To upgrade national reference materials for human papillomavirus (HPV) L1 genotyping,to improve the quality of HPV tests based on the L1 region.Methods Samples of 34 different HPV genotypes based on L1 fragment plasmids were developed and obtained.After being verified by commercial HPV assays,all samples were divided into a national reference standard.These samples of 34 different genotypes were then calibrated against the 1st WHO IS for HPV Type 16 DNA using real-time PCR.A collaborative study was performed to assess the reliability of the references and determine any requirements.Meanwhile,the stability of the National Reference Panel was evaluated.Results National reference materials consist of 34 different types of HPV samples and five HPV-negative pathogens,including the HPV68a and HPV68b subtypes.The DNA content of the 34 different types of HPV ranged from 6.26～7.08 Log10 IU/mL.The accuracy of each reagent should be capable of detecting all types within the detection range,ensuring correct,typing,and maintaining a detection limit not exceeding 104 IU/reaction.Conclusion The next-generation National Reference Panel for the L1 region of Human Papillomavirus genotyping has been successfully established.It is intended to assess the performance of HPV NAT.
Human papillomavirusNucleic acids detection kitL1National reference materials
万方数据
维普
