Comparison of the AdvanSure HPV GenoBlot assay with the INNO-LiPA HPV genotyping assay for human papillomavirus genotyping.

BACKGROUND

Persistent infection with oncogenic human papillomavirus (HPV) genotypes has been shown to be necessary for the development of cervical cancer. The recently developed AdvanSure HPV GenoBlot assay (AdvanSure assay) is based on real-time PCR amplification and reverse line-blot hybridization.

OBJECTIVE

We first evaluated the performance of the AdvanSure assay compared to the INNO-LiPA HPV Genotyping assay (INNO-LiPA assay) for the molecular genotyping of HPV.

STUDY DESIGN

A total of 200 cervical swab specimens were genotyped by the AdvanSure and INNO-LiPA assays. The AdvanSure and INNO-LiPA assays can detect 35 and 28 HPV genotypes, respectively. Samples that showed discrepancy were genotyped using sequencing.

RESULTS

The percent agreement between the two assays ranged from 95.4 to 100% according to genotype. Analyzing the kappa values showed almost perfect agreement (>0.9) for high-risk HPV genotypes 16, 18 and 33 and substantial agreement (0.724) for HPV genotype 31. The positive rates of the two assays for frequent HPV genotypes (16, 18, 31, 33, 53, 58, 66, 68, and 70) were not statistically different, but the INNO-LiPA assay showed higher positive rates than the AdvanSure assay for HPV genotypes 51, 52, and 56 (P<0.05). All HPV genotypes that can be detected by only the AdvanSure assay (HPV genotypes 32, 34, 42, 55, 61, 62, and 81) were confirmed by sequencing.

CONCLUSION

The AdvanSure assay was comparable with the well-established INNO-LiPA assay. The AdvanSure assay is a new alternative test for HPV genotyping in clinical laboratories.