Annals of Clinical Microbiology, The official Journal of the Korean Society of Clinical Microbiology

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pISSN 2288-0585 eISSN 2288-6850

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

Original article

Annals of Clinical Microbiology (Ann Clin Microbiol) 2018 December, Volume 21, Issue 4, pages 86-91.

https://doi.org/10.5145/ACM.2018.21.4.86

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

Yi Hyeon Kim, Hae-Sun Chung, Miae Lee

Department of Laboratory Medicine, Ewha Womans University College of Medicine, Seoul, Korea

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. (Ann Clin Microbiol 2018;21:86- 91)

Keywords

Genotype, Human papillomavirus, Multiplex real-time polymerase chain reaction