Skip to main content
Top
Published in: Archives of Virology 2/2016

01-02-2016 | Brief Report

Clinical validation of a novel real-time human papillomavirus assay for simultaneous detection of 14 high-risk HPV type and genotyping HPV type 16 and 18 in China

Authors: Hui Yang, Lie-Jun Li, Long-Xu Xie, Zhao-Yun Luo, Min Lu, Min Lin, Xiang-bin Zheng, Yue Huang, Li-Ye Yang

Published in: Archives of Virology | Issue 2/2016

Login to get access

Abstract

In the present study, we describe the laboratory workflow and the clinical validation of a novel multiplex real-time PCR-based HPV assay in China. The cross-sectional validation analysis showed that this assay worked well for detection of 14 HR-HPV types and identification of HPV 16 and 18 in a single sensitive assay that is suitable for both clinical usage and high-throughput cervical screening purposes. We predict that this accurate, high-throughput and low-cost HPV assay can greatly reduce the heavy economic burden of HPV detection in China.
Literature
1.
go back to reference Arbyn M, Castellsagué X, de Sanjosé S, Bruni L, Saraiya M, Bray F, Ferlay J (2011) Worldwide burden of cervical cancer in 2008. Ann Oncol 22:2675–2686CrossRefPubMed Arbyn M, Castellsagué X, de Sanjosé S, Bruni L, Saraiya M, Bray F, Ferlay J (2011) Worldwide burden of cervical cancer in 2008. Ann Oncol 22:2675–2686CrossRefPubMed
2.
go back to reference Forouzanfar MH, Foreman KJ, Delossantos AM, Lozano R, Lopez AD, Murray CJ, Naghavi M (2011) Breast and cervical cancer in 187 countries between 1980 and 2010: a systematic analysis. Lancet 378:1461–1484CrossRefPubMed Forouzanfar MH, Foreman KJ, Delossantos AM, Lozano R, Lopez AD, Murray CJ, Naghavi M (2011) Breast and cervical cancer in 187 countries between 1980 and 2010: a systematic analysis. Lancet 378:1461–1484CrossRefPubMed
3.
go back to reference Trottier H, Burchell AN (2009) Epidemiology of mucosal human papillomavirus infection and associated diseases. Public Health Genomics 12:291–307CrossRefPubMed Trottier H, Burchell AN (2009) Epidemiology of mucosal human papillomavirus infection and associated diseases. Public Health Genomics 12:291–307CrossRefPubMed
4.
go back to reference Anttila A, Kotaniemi-Talonen L, Leinonen M, Hakama M, Laurila P, Tarkkanen J, Malila N, Nieminen P (2010) Rate of cervical cancer, severe intraepithelial neoplasia, and adenocarcinoma in situ in primary HPV DNA screening with cytology triage: randomised study within organised screening programme. BMJ 340:c1804PubMedCentralCrossRefPubMed Anttila A, Kotaniemi-Talonen L, Leinonen M, Hakama M, Laurila P, Tarkkanen J, Malila N, Nieminen P (2010) Rate of cervical cancer, severe intraepithelial neoplasia, and adenocarcinoma in situ in primary HPV DNA screening with cytology triage: randomised study within organised screening programme. BMJ 340:c1804PubMedCentralCrossRefPubMed
5.
go back to reference Bulkmans NW, Berkhof J, Rozendaal L, van Kemenade FJ, Boeke AJ, Bulk S, Voorhorst FJ, Verheijen RH, van Groningen K, Boon ME, Ruitinga W, van Ballegooijen M, Snijders PJ, Meijer CJ (2007) Human papillomavirus DNA testing for the detection of cervical intraepithelial neoplasia grade 3 and cancer: 5-year follow-up of a randomised controlled implementation trial. Lancet 370:1764–1772CrossRefPubMed Bulkmans NW, Berkhof J, Rozendaal L, van Kemenade FJ, Boeke AJ, Bulk S, Voorhorst FJ, Verheijen RH, van Groningen K, Boon ME, Ruitinga W, van Ballegooijen M, Snijders PJ, Meijer CJ (2007) Human papillomavirus DNA testing for the detection of cervical intraepithelial neoplasia grade 3 and cancer: 5-year follow-up of a randomised controlled implementation trial. Lancet 370:1764–1772CrossRefPubMed
6.
go back to reference Ronco G, Giorgi-Rossi P, Carozzi F, Confortini M, Dalla Palma P, Del Mistro A, Ghiringhello B, Girlando S, Gillio-Tos A, De Marco L, Naldoni C, Pierotti P, Rizzolo R, Schincaglia P, Zorzi M, Zappa M, Segnan N, Cuzick J, New Technologies for Cervical Cancer screening (NTCC) Working Group (2010) Efficacy of human papillomavirus testing for the detection of invasive cervical cancers and cervical intraepithelial neoplasia: a randomised controlled trial. Lancet Oncol 11:249–257CrossRefPubMed Ronco G, Giorgi-Rossi P, Carozzi F, Confortini M, Dalla Palma P, Del Mistro A, Ghiringhello B, Girlando S, Gillio-Tos A, De Marco L, Naldoni C, Pierotti P, Rizzolo R, Schincaglia P, Zorzi M, Zappa M, Segnan N, Cuzick J, New Technologies for Cervical Cancer screening (NTCC) Working Group (2010) Efficacy of human papillomavirus testing for the detection of invasive cervical cancers and cervical intraepithelial neoplasia: a randomised controlled trial. Lancet Oncol 11:249–257CrossRefPubMed
7.
go back to reference Sankaranarayanan R, Nene BM, Shastri SS, Jayant K, Muwonge R, Budukh AM, Hingmire S, Malvi SG, Thorat R, Kothari A, Chinoy R, Kelkar R, Kane S, Desai S, Keskar VR, Rajeshwarkar R, Panse N, Dinshaw KA (2009) HPV screening for cervical cancer in rural India. N Engl J Med 360:1385–1394CrossRefPubMed Sankaranarayanan R, Nene BM, Shastri SS, Jayant K, Muwonge R, Budukh AM, Hingmire S, Malvi SG, Thorat R, Kothari A, Chinoy R, Kelkar R, Kane S, Desai S, Keskar VR, Rajeshwarkar R, Panse N, Dinshaw KA (2009) HPV screening for cervical cancer in rural India. N Engl J Med 360:1385–1394CrossRefPubMed
8.
go back to reference Laudadio J (2013) Human papillomavirus detection: testing methodologies and their clinical utility in cervical cancer screening. Adv Anat Pathol 20:158–167CrossRefPubMed Laudadio J (2013) Human papillomavirus detection: testing methodologies and their clinical utility in cervical cancer screening. Adv Anat Pathol 20:158–167CrossRefPubMed
9.
go back to reference Saslow D, Solomon D, Lawson HW et al (2012) American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol 137:516–542CrossRefPubMed Saslow D, Solomon D, Lawson HW et al (2012) American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol 137:516–542CrossRefPubMed
10.
go back to reference Meijer CJ, Berkhof J, Castle PE, Hesselink AT, Franco EL, Ronco G, Arbyn M, Bosch FX, Cuzick J, Dillner J, Heideman DA, Snijders PJ (2009) Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int J Cancer 124:516–520PubMedCentralCrossRefPubMed Meijer CJ, Berkhof J, Castle PE, Hesselink AT, Franco EL, Ronco G, Arbyn M, Bosch FX, Cuzick J, Dillner J, Heideman DA, Snijders PJ (2009) Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int J Cancer 124:516–520PubMedCentralCrossRefPubMed
11.
go back to reference Stoler MH, Castle PE, Solomon D, Schiffman M, American Society for Colposcopy and Cervical Pathology (2007) The expanded use of HPV testing in gynecologic practice per ASCCP-guided management requires the use of well validated assays. Am J Clin Pathol 127:335–337CrossRefPubMed Stoler MH, Castle PE, Solomon D, Schiffman M, American Society for Colposcopy and Cervical Pathology (2007) The expanded use of HPV testing in gynecologic practice per ASCCP-guided management requires the use of well validated assays. Am J Clin Pathol 127:335–337CrossRefPubMed
12.
go back to reference Eklund C, Zhou T, Dillner J, WHO Human Papillomavirus Laboratory Network (2010) Global proficiency study of human papillomavirus genotyping. J Clin Microbiol 48:4147–4155PubMedCentralCrossRefPubMed Eklund C, Zhou T, Dillner J, WHO Human Papillomavirus Laboratory Network (2010) Global proficiency study of human papillomavirus genotyping. J Clin Microbiol 48:4147–4155PubMedCentralCrossRefPubMed
13.
go back to reference Khan MJ, Castle PE, Lorincz AT, Wacholder S, Sherman M, Scott DR, Rush BB, Glass AG, Schiffman M (2005) The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst 97:1072–1079CrossRefPubMed Khan MJ, Castle PE, Lorincz AT, Wacholder S, Sherman M, Scott DR, Rush BB, Glass AG, Schiffman M (2005) The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst 97:1072–1079CrossRefPubMed
14.
go back to reference Kjær SK, Frederiksen K, Munk C, Iftner T (2010) Long-term absolute risk of cervical intraepithelial neoplasia grade 3 or worse following human papillomavirus infection: role of persistence. J Natl Cancer Inst 102:1478–1488PubMedCentralCrossRefPubMed Kjær SK, Frederiksen K, Munk C, Iftner T (2010) Long-term absolute risk of cervical intraepithelial neoplasia grade 3 or worse following human papillomavirus infection: role of persistence. J Natl Cancer Inst 102:1478–1488PubMedCentralCrossRefPubMed
16.
go back to reference Lin M, Yang LY, Li LJ, Wu JR, Peng YP, Luo ZY (2008) Genital human papillomavirus screening by gene chip in Chinese women of Guangdong province. Aust N Z J Obstet Gynaecol 48:189–194CrossRefPubMed Lin M, Yang LY, Li LJ, Wu JR, Peng YP, Luo ZY (2008) Genital human papillomavirus screening by gene chip in Chinese women of Guangdong province. Aust N Z J Obstet Gynaecol 48:189–194CrossRefPubMed
17.
go back to reference Chen Q, Xie LX, Qing ZR, Li LJ, Luo ZY, Lin M, Zhang SM, Chen WZ, Lin BZ, Lin QL, Li H, Chen WP, Zheng PY, Mao LZ, Chen CY, Yang C, Zhan YZ, Liu XZ, Zheng JK, Yang LY (2012) Epidemiologic characterization of human papillomavirus infection in rural Chaozhou, eastern Guangdong Province of China. PLoS One 7:e32149PubMedCentralCrossRefPubMed Chen Q, Xie LX, Qing ZR, Li LJ, Luo ZY, Lin M, Zhang SM, Chen WZ, Lin BZ, Lin QL, Li H, Chen WP, Zheng PY, Mao LZ, Chen CY, Yang C, Zhan YZ, Liu XZ, Zheng JK, Yang LY (2012) Epidemiologic characterization of human papillomavirus infection in rural Chaozhou, eastern Guangdong Province of China. PLoS One 7:e32149PubMedCentralCrossRefPubMed
18.
go back to reference Hesselink AT, Berkhof J, van der Salm ML, van Splunter AP, Geelen TH, van Kemenade FJ, Bleeker MG, Heideman DA (2014) Clinical validation of the HPV-risk assay, a novel real-time PCR assay for detection of high-risk human papillomavirus DNA by targeting the E7 region. J Clin Microbiol 52:890–896PubMedCentralCrossRefPubMed Hesselink AT, Berkhof J, van der Salm ML, van Splunter AP, Geelen TH, van Kemenade FJ, Bleeker MG, Heideman DA (2014) Clinical validation of the HPV-risk assay, a novel real-time PCR assay for detection of high-risk human papillomavirus DNA by targeting the E7 region. J Clin Microbiol 52:890–896PubMedCentralCrossRefPubMed
Metadata
Title
Clinical validation of a novel real-time human papillomavirus assay for simultaneous detection of 14 high-risk HPV type and genotyping HPV type 16 and 18 in China
Authors
Hui Yang
Lie-Jun Li
Long-Xu Xie
Zhao-Yun Luo
Min Lu
Min Lin
Xiang-bin Zheng
Yue Huang
Li-Ye Yang
Publication date
01-02-2016
Publisher
Springer Vienna
Published in
Archives of Virology / Issue 2/2016
Print ISSN: 0304-8608
Electronic ISSN: 1432-8798
DOI
https://doi.org/10.1007/s00705-015-2673-y

Other articles of this Issue 2/2016

Archives of Virology 2/2016 Go to the issue
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.