Annals of Clinical Microbiology

The Korean Society of Clinical Microbiology (대한임상미생물학회)
권호 표지
DOI QR코드

DOI QR Code

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

인유두종바이러스 유전자형 검사법 PANA RealTyper HPV Kit와 AdvanSure HPV GenoBlot Assay의 비교

  • Kim, Yi Hyeon (Department of Laboratory Medicine, Ewha Womans University College of Medicine) ;
  • Chung, Hae-Sun (Department of Laboratory Medicine, Ewha Womans University College of Medicine) ;
  • Lee, Miae (Department of Laboratory Medicine, Ewha Womans University College of Medicine)
  • 김이현 (이화여자대학교 의과대학 진단검사의학교실) ;
  • 정혜선 (이화여자대학교 의과대학 진단검사의학교실) ;
  • 이미애 (이화여자대학교 의과대학 진단검사의학교실)
  • Received : 2018.05.02
  • Accepted : 2018.10.04
  • Published : 2018.12.20
⟨ Previous Next ⟩

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.

배경: PANA RealTyper HPV kit (PANAGENE, Korea; PANA RealTyper)는 multiplex real-time PCR과 melting curve analysis를 이용하여 human papillomavirus (HPV)의 유전자형을 검출한다. 본 연구에서는 PANA Real Typer와 AdvanSure HPV GenoBlot assay (LG Life Sciences, Korea; AdvanSure assay)를 비교하였다. 방법: 자궁경부암 검진을 받은 환자에서 채취한 검체를 60개 수집하였다. AdvanSure assay와 PANA RealTyper는 고위험군 HPV 20종을 검출할 수 있다. 저위험군 HPV의 경우 AdvanSure assay는 15종을, PANA RealTyper는 2종의 유전자형을 구별할 수 있고 18종의 유전자형을 검출할 수 있다. 결과: 총 60개 중 40개 검체에서 54개의 고위험군 유전자형이 검출되었으며 18개 검체에서 20개의 저위험군 유전자형이 검출되었다. 고위험군에서 두 방법 간 일치율은 94.4-100%였다. PANA Real Typer에서만 양성으로 검출된 9개 유전자형 중 7개(HPV 16 (n=1), 39 (n=1), 52 (n=1), 58 (n=2), 68 (n=2))은 진양성으로 판별되었다. AdvanSure assay에서만 양성으로 나온 4개 유전자형 중 3개는 HPV 59였다. 저위험군에서 AdvanSure assay에서 검출된 19개 유전자형 중 HPV 6 2개, HPV 11 1개였다. HPV 6 중 한 개는 PANA RealTyper에서만 양성이었다. 결론: PANA RealTyper는 AdvanSure assay와 동등한 검출력을 보였으며, 임상 검사실에서 HPV 유전자형 검사에 유용하게 쓰일 수 있을 것으로 생각한다.

Keywords

Acknowledgement

Supported by : National Research Foundation of Korea (NRF)

References

  1. Burd EM. Human papillomavirus and cervical cancer. Clin Microbiol Rev 2003;16:1-17. https://doi.org/10.1128/CMR.16.1.1-17.2003
  2. Koliopoulos G, Nyaga VN, Santesso N, Bryant A, Martin-Hirsch PP, Mustafa RA, et al. Cytology versus HPV testing for cervical cancer screening in the general population. Cochrane Database Syst Rev 2017;8:CD008587.
  3. You W, Li S, Du R, Zheng J, Shen A. Epidemiological study of high-risk human papillomavirus infection in subjects with abnormal cytological findings in cervical cancer screening. Exp Ther Med 2018;15:412-8.
  4. Lagheden C, Eklund C, Lamin H, Kleppe SN, Lei J, Elfstrom KM, et al. Nationwide comprehensive human papillomavirus (HPV) genotyping of invasive cervical cancer. Br J Cancer 2018;118:1377-81. https://doi.org/10.1038/s41416-018-0053-6
  5. Kaur P, Aggarwal A, Nagpal M, Oberoi L, Sharma S. Prevalence and clinical utility of human papilloma virus genotyping in patients with cervical lesions. J Obstet Gynaecol India 2014;64:279-83. https://doi.org/10.1007/s13224-014-0508-5
  6. Moreau F, Fetouchi R, Micalessi I, Brejeon V, Bacon N, Jannes G, et al. Detection and genotyping of human papillomavirus by real-time PCR assay. J Clin Virol 2013;56:244-9.
  7. CLSI. User protocol for evaluation of qualitative test performance;approved guideline-second edition. CLSI document EP12-A2. Wayne, PA: Clinical and Laboratory Standards Institute;2008.
  8. Poljak M, Kocjan BJ, Ostrbenk A, Seme K. Commercially available molecular tests for human papillomaviruses (HPV): 2015 update. J Clin Virol 2016;76 Suppl 1:S3-13. https://doi.org/10.1016/j.jcv.2015.10.023
  9. Poljak M and Kocjan BJ. Commercially available assays for multiplex detection of alpha human papillomaviruses. Expert Rev Anti Infect Ther 2010;8:1139-62. https://doi.org/10.1586/eri.10.104
  10. Kahng J, Oh EJ, Lee HN, Lee DW, Kim Y. Clinical validation of AdvanSure GenoBlot assay as primary screening and test of cure for human papillomavirus infection. Ann Lab Med 2014;34:127-33. https://doi.org/10.3343/alm.2014.34.2.127
  11. Chung HS and Lee M. Comparison of the AdvanSure HPV GenoBlot assay with the INNO-LiPA HPV genotyping assay for human papillomavirus genotyping. J Clin Virol 2014;60:34-8. https://doi.org/10.1016/j.jcv.2014.01.027
  12. Liao Y, Zhou Y, Guo Q, Xie X, Luo E, Li J, et al. Simultaneous detection, genotyping, and quantification of human papillomaviruses by multicolor real-time PCR and melting curve analysis. J Clin Microbiol 2013;51:429-35. https://doi.org/10.1128/JCM.02115-12