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

Yi Hyeon Kim; Hae-Sun Chung; Miae Lee

doi:10.5145/ACM.2018.21.4.86

Journal List > Ann Clin Microbiol > v.21(4) > 1109549

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Kim, Chung, and Lee: Comparison of PANA RealTyper HPV Kit with AdvanSure HPV GenoBlot Assay for Human Papillomavirus Genotyping

Original Article

Annals of Clinical Microbiology 2018; 21(4): 86-91.

Published online: 20 December 2018

DOI: 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.

Correspondence: Hae-Sun Chung, Department of Laboratory Medicine, Ewha Womans University College of Medicine, 1071 Anyangcheon-ro, Yangcheon-gu, Seoul 07985, Korea. (Tel) 82-2-2650-5043, (Fax) 82-2-2650-5091, sunny0521.chung@ewha.ac.kr

Received 2 May 2018 Revised 1 October 2018 Accepted 4 October 2018

The Korean Society of Clinical Microbiology

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

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

Figures and Tables

Table 1

Identification of genotypes by AdvanSure assay and PANA RealTyper

Table 2

Multiple genotypes from each specimen presented by AdvanSure assay and PANA RealTyper

Table 3

Agreement of HPV genotypes between AdvanSure assay and PANA RealTyper

^*Positive percent agreement cannot be calculated because denominator is zero.

Abbreviation: CI, confidence interval.

Table 4

Discordant results of AdvanSure assay and PANA RealTyper

ACKNOWLEDGMENTS

This work was supported by the National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT) (No. 2017R1C1B5017422).

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