Objective: To develop a new platform for genotyping human papillomavirus(HPV) and to investigate its effect in clinical application.
Methods: By combining L1 consensus PCR and multiplex hybridization using a Luminex xMAP system-based suspension array, we developed a rapid high-throughput assay,the HPV DNA suspension array (HPV-SA), capable of simultaneously typing 30 HPVs, including 18 high-risk HPV genotypes and 12 low-risk HPV genotypes. 810 clinical specimens were used to investigate the effect of HPV-SA. Veracity of the genotyping result was verified by E7 type-specific PCR-DNA sequencing.
Results: Among the 810 clinical specimens, 243 were found to be HPV positive,including high-risk HPV subtypes 16, 18, 26, 31, 33, 39, 45, 51, 53, 56, 58, 59, 66, 68, 73 and 82,and low-risk HPV6, 11, 34, 54, 61, 67, 70 and 84. The sensitivity tested by standard samples was up to 10 copies of HPV DNA.
Conclusion: The HPV-SA developed here showed high sensitivity and specificity, suitable to be applied in clinical practice for HPV diagnosis and investigation on the prevalence of HPV sub-types.
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