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Analytical Performance of Sensitivity and Specificity for Rapid Multiplex High Risk Human Papillomavirus Detection Kit: HPV ViroCheck

고위험군 HPV 검출을 위한 분석적 민감도와 특이도 성능평가

  • Park, Sunyoung (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Yoon, Hyeonseok (Optipharm M&D, Inc., Wonju Eco Environmental Technology Center) ;
  • Bang, Hyeeun (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Kim, Yeun (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Choi, Seongkyung (Optipharm M&D, Inc., Wonju Eco Environmental Technology Center) ;
  • Ahn, Sungwoo (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Kim, Jungho (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Lee, Suji (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Yang, Ji Yeong (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Lee, Dongsup (Department of Clinical Laboratory Science, Hyejeon College)
  • 박선영 (연세대학교 임상병리학과) ;
  • 윤현석 (옵티팜 엠엔디) ;
  • 방혜은 (연세대학교 임상병리학과) ;
  • 김연 (연세대학교 임상병리학과) ;
  • 최성경 (옵티팜 엠엔디) ;
  • 안성우 (연세대학교 임상병리학과) ;
  • 김정호 (연세대학교 임상병리학과) ;
  • 이수지 (연세대학교 임상병리학과) ;
  • 양지영 (연세대학교 임상병리학과) ;
  • 이동섭 (혜전대학교 임상병리과)
  • Received : 2017.10.12
  • Accepted : 2017.11.01
  • Published : 2017.12.31

Abstract

Human papillomaviruses (HPVs) are major causes of cervical cancer. Sixteen high risk HPVs, including HPV 16, HPV 18, HPV31, HPV 33, HPV 35, HPV 39, HPV 45, HPV 51, HPV 52, HPV 53, HPV 56, HPV 58, HPV 59, HPV 66, HPV 68, and HPV 69 are found in cervical cancer. HPVs 16 and 18 are mainly presented in 70% of cervical cancer. Therefore, identifying the presence of these high-risk HPVs is crucial. The objective of this study is to establish the HPV ViroCheck for detecting 16 HR-HPVs and genotypes of HPVs 16 and 18, as well as to analyze the analytical performance of HPV ViroCheck. We performed the analytical sensitivity of HPV E6 / E7 genes of 16 high risk HPVs to confirm the limit of detection. Then, a cross reactivity of HPV ViroCheck with microorganisms and viruses related to the cervix were analyzed for analytical specificity. Analytical sensitivity of high risk HPV genotypes ranged from 1 to 100 copies when using cloned DNAs. The limit of detection was 10 cells for both SiHa and HeLa cells. Cervical-related microorganisms and viruses did not show cross-reactivity to HPV DNA. Moreover, the intra- and inter-assay coefficient variations (CVs) were below 5%. In conclusion, HPV Virocheck will be useful for the detection of 16 HR HPVs, as well as HPV 16 and HPV 18 genotypes rapidly.

Acknowledgement

Supported by : Hyejeon College

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