Comparison of PANA RealTyper HPV Kit with AdvanSure HPV GenoBlot Assay for Human Papillomavirus Genotyping / 대한임상미생물학회지

ABSTRACT

BACKGROUND: The PANA RealTyper HPV kit (PANAGENE, Korea; PANA RealTyper) was developed to genotype human papillomavirus (HPV) and was based on multiplex real-time PCR amplification and melting curve analysis. In this study, we compared PANA RealTyper to the AdvanSure HPV GenoBlot assay (LG Life Sciences, Korea; AdvanSure assay) and attempted to evaluate the performance of PANA RealTyper. METHODS: A total of 60 cervical specimens were collected from women undergoing routine cervical cancer screening. The AdvanSure assay and PANA RealTyper kit identified the same 20 high-risk genotypes. However, the AdvanSure assay identified 15 low-risk genotypes, while the PANA RealTyper kit identified only 2 but detected 18 low-risk genotypes. RESULTS: Among the total 60 specimens, 54 high-risk genotypes (40 specimens) and 20 low-risk genotypes (18 specimens) were detected. The agreement rates of the assays ranged from 94.4 to 100% for high-risk genotypes. Among 9 genotypes that were positive in the PANA RealTyper kit but negative in the AdvanSure assay, 7 were confirmed as true positive (HPV genotypes 16 (n=1), 39 (n=1), 52 (n=1), 58 (n=2), 68 (n=2)). Among 4 genotypes that were negative in the PANA RealTyper kit but positive in the AdvanSure assay, 3 were confirmed as HPV genotype 59. Among the 19 low-risk genotypes positive in the AdvanSure assay, there were 2 cases of HPV 6 and 1 case of HPV 11. In comparison, only 1 positive case of HPV 6 was determined by the PANA RealTyper kit. CONCLUSION: The PANA RealTyper kit was comparable with the AdvanSure assay. The PANA RealTyper kit would be useful and suitable for HPV genotyping in the clinical laboratory.