Analytical Performance of Sensitivity and Specificity for Rapid Multiplex High Risk Human Papillomavirus Detection Kit: HPV ViroCheck
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초록
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.
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.
참고문헌 (27)
- Forman D, "Global burden of human papillomavirus and related diseases", Vaccine, 30(Suppl 5), pp.F12~F23 (2012)
- Munoz N, "Epidemiologic classification of human papillomavirus types associated with cervical cancer", N Engl J Med, 348(6), pp.518~527 (2003)
- Kjaer SK, "Carcinogenic HPV prevalence and age-specific type distribution in 40,382 women with normal cervical cytology, ASCUS", LSIL, HSIL, or cervical cancer:what is the potential for prevention?, 2014, pp.25(2), 179~189
- Castle PE, "Screening to prevent invasive cervical cancer: ASCO resource-stratified clinical practice guideline", J Clin Oncol, 35(11), pp.1250~1252 (2017)
- Castle PE, "Benefits and risks of HPV testing in cervical cancer screening", Lancet Oncol, 11(3), pp.214~215 (2010)
- Herbert A, "Primary HPV testing: a proposal for co-testing in initial rounds of screening to optimise sensitivity of cervical cancer screening", Cytopathology, 28(1), pp.9~15 (2017)
- 민경진, "The Korean guideline for cervical cancer screening", Journal of Gynecologic Oncology, 26(3), pp.232~239 (2015), 대한부인종양학회
- 이재관, "Practice guidelines for the early detection of cervical cancer in Korea: Korean Society of Gynecologic Oncology and the Korean Society for Cytopathology 2012 edition", Journal of Gynecologic Oncology, 24(2), pp.186~203 (2013), 대한부인종양학회
- Ratnam S, "Clinical performance of the PreTect HPV-Proofer E6", E7mRNA assay in comparison with that of the Hybrid Capture 2test for identification of women at risk of cervical cancer, 2010, pp.48(8), 2779~2785
- 김윤식, "Inhibition of Cervical Cancer Cell Growth by Gene Silencing of HPV16 E6 Induced by Short-interfering RNA", 대한임상검사과학회지, 43(3), pp.89~97 (2011), 대한임상검사과학회
- Thomas M, "The role of the E6-p53 interaction in the molecular pathogenesis of HPV", Oncogene, 18(53), pp.7690~7700 (1999)
- Storey A, "Role of a p53 polymorphism in the development of human papillomavirus-associated cancer", Nature, 393(6682), pp.229~234 (1998)
- Caldeira S, "Analysis of E7", Rb associations, 2005, pp.119, 363~379
- 이준범, "Investigation of Detected by Recent Various Human Papillomavirus from General Hospital in Seoul Area", 대한임상검사과학회지, 48(3), pp.247~254 (2016), 대한임상검사과학회
- Munkhdelger J, "Performance of HPV E6", E7 mRNA RT-qPCR for screening and diagnosis of cervical cancer with Thinprep pap test samples, 2014, pp.97(2), 279~284
- Kim JH, "Evaluation of the Punch-itTM NA-Sample kit for detecting microbial DNA in blood culture bottles using PCR-reverse blot hybridization assay", Journal of Microbiological Methods, 128, pp.24~30 (2016)
- Walsh PS, "Chelex 100 as a medium for simple extraction of DNA for PCR-based typing from forensic material", Biotechniques, 10(4), pp.506~513 (1991)
- Mincheva A, "Chromosomal integration sites of human papillomavirus DNA in three cervical cancer cell lines mapped by in situ hybridization", Med Microbiol Immunol, 176(5), pp.245~256 (1987)
- Terry G, "Detection of high-risk HPV types by the hybrid capture 2 test", J Med Virol, 65(1), pp.155~162 (2001)
- Du Chateau BK, "Clinical laboratory experience with cervista HPV HR as a function of cytological classification: comparison with retrospective digene HC2high-risk HPV DNA test data", J Clin Microbiol, 51(3), pp.1057~1058 (2013)
- Zhou F, "Sensitivity of high-risk HPV Hybrid Capture II (hrHPV HC2) test using SurePath(TM) specimens in the prediction of cervical high-grade squamous lesions", Diagn Cytopathol, 43(5), pp.381~387 (2015)
- Huijsmans CJ, "HPV prevalence in the Dutch cervical cancer screening population (DuSC study): HPV testing using automated HC2, cobas and aptima workflows", BMC Cancer, 16, pp.922~ (2016)
- Kash N, "Safety and efficacy data on vaccines and immunization to human papillomavirus", J Clin Med, 4(4), pp.614~633 (2015)
- Yang A, "Perspectives for therapeutic HPV vaccine development", J Biomed Sci, 23, pp.75~ (2016)
- Kim TJ, "Clearance of persistent HPV infection and cervical lesion by therapeutic DNA vaccine in CIN3 Patients", Nat Commun, 30, pp.5317~ (2014)
- Trimble CL, "Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2", 3: a randomised, double-blind, placebocontrolled phase 2b trial, 2015, pp.386(10008), 2078~2088
- Morrow MP, "Augmentation of cellular and humoral immune responses to HPV16 and HPV18 E6 and E7 antigens by VGX-3100", Mol Ther Oncolytics, 3, pp.16025~ (2016)