Performance of the New INNO-LiPA HPV extra to genotype human papillomavirus in cervical cell specimens.

OBJECTIVE: It was our aim to compare the INNO-LiPA HPV Genotyping Extra (LiPA; Innogenetics) versus the Linear Array test (LA; Roche) in cervical samples.

STUDY DESIGN: One hundred cervical samples were selected, obtained from a cancer prevention center. All samples were human papillomavirus (HPV) DNA positive by Hybrid Capture 2 HPV test and genotyped by LA HPV genotyping test. All data were analyzed using Cohen's κ tests. κ values ranged from poor, fair, moderate and good to very good agreement strength.

RESULTS: Detection of multiple infection and HPV genotypes per sample was higher by LA than by LiPA (61.5 vs. 52.1 and 2.2 vs. 1.7%, respectively). There were concordant results in 65 samples and compatible results in 33 samples. Only 2 samples were considered as discordant. In 21 samples, additional types were detected by LA, and in 13 samples, additional types were detected by LiPA. Analyzing the κ values, we have found very good agreement for 14 genotypes (6, 16, 26, 31, 33, 35, 45, 51, 52, 53, 58, 66, 68 and 70).

CONCLUSIONS: We considered that the new LiPA is highly comparable with other methods and suitable for clinical and epidemiological studies.