Comparison of HPV sign genotyping test with INNO-LiPA HPV genotyping extra assay on histologic and cytologic cervical specimens.

An accurate tool for viral typing is important for management of patients with human papillomavirus (HPV) infection and to monitor HPV vaccine efficacy. This study evaluated the performance of the HPV sign® Genotyping Test by analyzing 87 archival cervical specimens and compared results with historical data by INNO-LiPA HPV Genotyping Extra assay. There was a substantial concordance for HPV detection in clinical samples (k 0.66), with an overall agreement rate of 85.1%. The genotyping overall agreement, considering one by one the HPV infection detected, was 95.7%. The HPV sign test showed, however, lower sensitivity than INNO-LiPA for HPV 31, 53, and 66. On the other hand, The HPV16 sensitivity was higher for HPV sign (90.0%, confidence interval [CI] 0.79-1.01) than for INNO-LiPA (83.3%, CI 0.70-0.97). Furthermore, HPV sign allowed identifying the presence of HPV16 intratype variants. In conclusion, HPV sign is a promising method for HPV genotyping and has revealed advantages in detecting a broad spectrum of HPV types and variants.