Evaluation of a Newly Developed GenoArray Human Papillomavirus (HPV) Genotyping Assay and Comparison with the Roche Linear Array HPV Genotyping Assay

Overview

Journal J Clin Microbiol

Specialty Microbiology

Date 2010 Jan 1

PMID 20042614

Citations 40

Authors

Stephanie S Liu

Rebecca C Y Leung

Karen K L Chan

Annie N Y Cheung

Hextan Y S Ngan

Affiliations

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Abstract

Persistent infection with high-risk types of human papillomavirus (HPV) is a necessary step in the development of cervical cancer. The incorporation of HPV detection into cervical screening programs may improve the ability to identify women at risk of cervical cancer. We recently evaluated the performance characteristics of a newly developed HPV detection assay, the GenoArray (GA) genotyping assay, for the detection of HPV infections by comparing it with the commercial Roche Linear Array (LA) HPV genotyping assay. The GA assay has an analytical sensitivity for the detection of HPV types 16 (HPV-16) and HPV-18 of as few as 10 to 50 copies, and its reproducibility is adequate. The GA and LA assays showed no significant difference in the rates of detection of genotypes detected by both HPV genotyping assays and oncogenic genotypes, and the interassay agreement was excellent. The GA and LA assays revealed either concordant or compatible genotyping results for 97.5% of the samples and discordant results for only eight (2.5%) samples. Compatible results were also observed for the detection of single or multiple HPV infections and the detection of most of the genotypes. The GA assay also demonstrated good clinical performance characteristics when the comparisons were carried out with clinical subgroups of samples from patients with normal cytologies, low-grade or high-grade squamous intraepithelial lesions, and cancers. Therefore, the GA assay appears to be highly sensitive and specific for the genotyping of HPV. It has the advantage that it specifically detects HPV-52, which overcomes a limitation of the LA assay, and hence, it has potential value for use for genotyping, especially in regions where HPV-52 has a high prevalence.

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References

Day S, Hudson A, Mast A, Sander T, Curtis M, Olson S . Analytical performance of the Investigational Use Only Cervista HPV HR test as determined by a multi-center study. J Clin Virol. 2009; 45 Suppl 1:S63-72. DOI: 10.1016/S1386-6532(09)70010-1. View

Ergunay K, Misirlioglu M, Firat P, Tuncer Z, Tuncer S, Yildiz I . [Detection and typing of human papilloma virus by polymerase chain reaction and hybridization assay in cervical samples with cytological abnormalities]. Mikrobiyol Bul. 2008; 42(2):273-82. View

Molijn A, Kleter B, Quint W, van Doorn L . Molecular diagnosis of human papillomavirus (HPV) infections. J Clin Virol. 2005; 32 Suppl 1:S43-51. DOI: 10.1016/j.jcv.2004.12.004. View

Munoz N, Bosch F, de Sanjose S, Herrero R, Castellsague X, Shah K . Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003; 348(6):518-27. DOI: 10.1056/NEJMoa021641. View

Viera A, Garrett J . Understanding interobserver agreement: the kappa statistic. Fam Med. 2005; 37(5):360-3. View

Grisaru D, Avidor B, Niv J, Marmor S, Almog B, Leibowitz C . Pilot study of prevalence of high-risk human papillomavirus genotypes in Israeli Jewish women referred for colposcopic examination. J Clin Microbiol. 2008; 46(5):1602-5. PMC: 2395108. DOI: 10.1128/JCM.02483-07. View

Clifford G, Rana R, Franceschi S, Smith J, Gough G, Pimenta J . Human papillomavirus genotype distribution in low-grade cervical lesions: comparison by geographic region and with cervical cancer. Cancer Epidemiol Biomarkers Prev. 2005; 14(5):1157-64. DOI: 10.1158/1055-9965.EPI-04-0812. View

Walboomers J, Jacobs M, Manos M, Bosch F, Kummer J, Shah K . Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999; 189(1):12-9. DOI: 10.1002/(SICI)1096-9896(199909)189:1<12::AID-PATH431>3.0.CO;2-F. View

Bulkmans N, Rozendaal L, Snijders P, Voorhorst F, Boeke A, Zandwijken G . POBASCAM, a population-based randomized controlled trial for implementation of high-risk HPV testing in cervical screening: design, methods and baseline data of 44,102 women. Int J Cancer. 2004; 110(1):94-101. DOI: 10.1002/ijc.20076. View

10.

Brink A, Snijders P, Meijer C . HPV detection methods. Dis Markers. 2007; 23(4):273-81. PMC: 3851620. DOI: 10.1155/2007/147429. View

11.

Cox J, Lorincz A, Schiffman M, Sherman M, Cullen A, Kurman R . Human papillomavirus testing by hybrid capture appears to be useful in triaging women with a cytologic diagnosis of atypical squamous cells of undetermined significance. Am J Obstet Gynecol. 1995; 172(3):946-54. DOI: 10.1016/0002-9378(95)90026-8. View

12.

Gravitt P, Schiffman M, Solomon D, Wheeler C, Castle P . A comparison of linear array and hybrid capture 2 for detection of carcinogenic human papillomavirus and cervical precancer in ASCUS-LSIL triage study. Cancer Epidemiol Biomarkers Prev. 2008; 17(5):1248-54. PMC: 2705141. DOI: 10.1158/1055-9965.EPI-07-2904. View

13.

Lin M, Yang L, Li L, Wu J, Peng Y, Luo Z . Genital human papillomavirus screening by gene chip in Chinese women of Guangdong province. Aust N Z J Obstet Gynaecol. 2008; 48(2):189-94. DOI: 10.1111/j.1479-828X.2008.00844.x. View

14.

Stevens M, Garland S, Rudland E, Tan J, Quinn M, Tabrizi S . Comparison of the Digene Hybrid Capture 2 assay and Roche AMPLICOR and LINEAR ARRAY human papillomavirus (HPV) tests in detecting high-risk HPV genotypes in specimens from women with previous abnormal Pap smear results. J Clin Microbiol. 2007; 45(7):2130-7. PMC: 1933009. DOI: 10.1128/JCM.02438-06. View

15.

Garland S, Cuzick J, Domingo E, Goldie S, Kim Y, Konno R . Recommendations for cervical cancer prevention in Asia Pacific. Vaccine. 2008; 26 Suppl 12:M89-98. DOI: 10.1016/j.vaccine.2008.06.020. View

16.

Castle P, Porras C, Quint W, Rodriguez A, Schiffman M, Gravitt P . Comparison of two PCR-based human papillomavirus genotyping methods. J Clin Microbiol. 2008; 46(10):3437-45. PMC: 2566086. DOI: 10.1128/JCM.00620-08. View

17.

Tay S, Ngan H, Chu T, Cheung A, Tay E . Epidemiology of human papillomavirus infection and cervical cancer and future perspectives in Hong Kong, Singapore and Taiwan. Vaccine. 2008; 26 Suppl 12:M60-70. DOI: 10.1016/j.vaccine.2008.05.042. View

18.

Sabol I, Salakova M, Smahelova J, Pawlita M, Schmitt M, Milutin Gasperov N . Evaluation of different techniques for identification of human papillomavirus types of low prevalence. J Clin Microbiol. 2008; 46(5):1606-13. PMC: 2395111. DOI: 10.1128/JCM.02328-07. View

19.

Shi J, Qiao Y, Smith J, Dondog B, Bao Y, Dai M . Epidemiology and prevention of human papillomavirus and cervical cancer in China and Mongolia. Vaccine. 2008; 26 Suppl 12:M53-9. DOI: 10.1016/j.vaccine.2008.05.009. View

20.

Bachtiary B, Obermair A, Dreier B, Birner P, Breitenecker G, Selzer E . Impact of multiple HPV infection on response to treatment and survival in patients receiving radical radiotherapy for cervical cancer. Int J Cancer. 2002; 102(3):237-43. DOI: 10.1002/ijc.10708. View