Clinical use of the Onclarity test with extended HPV genotyping and phenotyping in patients with suspected squamous intraepithelial lesions
, 3, 4, 5, 16
Abstract
Objectives: Human papillomavirus (HPV) is the most widespread virus with oncogenic potential that infects humans and
there is a need to look for the most effective screening method among the population. Understanding the role of HPV in
cervical dysplasia and viruses typing increased the usage of HPV-based cervical cancer screening tests using genotyping.
Material and methods: We aim to assess the usefulness the Onclarity Test with extended genotyping and phenotyping
of HPV in detecting cervical squamous intraepithelial lesions in 695 subjects who registered for regular cervical screening
or due to abnormal LBC result or positive HPV results.
Results: Incidence of positive HPV depended significantly on biopsy outcome (p < 0.001). It was the highest for patients
with HSIL (92.5%), lower for patients with LSIL (57.9%) and with HPV outcome of biopsy (50.0%). The sensitivity of positive
HPV for detecting HSIL was equal to 92.50% (95% CI: 79.61%–98.43%), and specificity equalled 55.26% (95% CI:
43.41–66.69%). Sensitivity of HPV positive for any of 16, 18, 31, 45, 51 or 52 genotypes but not belonging to the P1, P2 or
P3 group for detecting HSIL equalled 62.50% (95% CI: 45.80–77.27%), specificity equalled 72.37% (95% CI: 60.91–82.01%).
Conclusions: The Onclarity test is characterised by high sensitivity and specificity in detecting CIN2+ lesions. Extended
genotyping enables the identification of the most common oncogenic HPV types in the population. It can be used as a
basic tool for secondary prevention or together with LBC.
Keywords: HPVgenotypingphenotypingSILOnclarity
References
- Piña-Sánchez P. Human Papillomavirus: Challenges and Opportunities for the Control of Cervical Cancer. Arch Med Res. 2022; 53(8): 753–769.
- Shanmugasundaram S, You J. Targeting Persistent Human Papillomavirus Infection. Viruses. 2017; 9(8).
- Yeo-Teh NSL, Ito Y, Jha S. High-Risk Human Papillomaviral Oncogenes E6 and E7 Target Key Cellular Pathways to Achieve Oncogenesis. Int J Mol Sci. 2018; 19(6).
- Dizanzo MP, Marziali F, Brunet Avalos C, et al. HPV E6 and E7 oncoproteins cooperatively alter the expression of Disc Large 1 polarity protein in epithelial cells. BMC Cancer. 2020; 20(1): 293.
- Nowakowski A, Jach R, Szenborn L, et al. Recommendations of the Polish Society of Gynaecologists and Obstetricians, Polish Paediatric Society, Polish Society of Family Medicine, Polish Society of Vaccinology, Polish Society of Oncological Gynaecology, and Polish Society of Colposcopy and Pathophysiology of the Uterine Cervix on prophylactic vaccinations against infections with human papillomaviruses in Poland. Pediatr Pol. 2022; 97(3): 167–175.
- Araújo MG, Magalhães GM, Garcia LC, et al. Update on human papillomavirus - Part II: complementary diagnosis, treatment and prophylaxis. An Bras Dermatol. 2021; 96(2): 125–138.
- Zhu Y, Wang Y, Hirschhorn J, et al. Human Papillomavirus and Its Testing Assays, Cervical Cancer Screening, and Vaccination. Adv Clin Chem. 2017; 81: 135–192.
- Swid MA, Monaco SE. Should screening for cervical cancer go to primary human papillomavirus testing and eliminate cytology? Mod Pathol. 2022; 35(7): 858–864.
- Roe CJ, Hanley KZ. Updates in Cervical Cytology: The 90-Year-Long Journey from Battle Creek to Today. Surg Pathol Clin. 2018; 11(3): 589–599.
- Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021; 71(3): 209–249.
- Zhang J, Cheng K, Wang Z. Prevalence and distribution of human papillomavirus genotypes in cervical intraepithelial neoplasia in China: a meta-analysis. Arch Gynecol Obstet. 2020; 302(6): 1329–1337.
- Przybylski M, Pruski D, Wszołek K, et al. Prevalence of HPV and Assessing Type-Specific HPV Testing in Cervical High-Grade Squamous Intraepithelial Lesions in Poland. Pathogens. 2023; 12(2).
- Iacobone AD, Bottari F, Radice D, et al. Distribution of High-Risk Human Papillomavirus Genotypes and Multiple Infections in Preneoplastic and Neoplastic Cervical Lesions of Unvaccinated Women: A Cross-sectional Study. J Low Genit Tract Dis. 2019; 23(4): 259–264.
- Radley D, Saah A, Stanley M. Persistent infection with human papillomavirus 16 or 18 is strongly linked with high-grade cervical disease. Hum Vaccin Immunother. 2016; 12(3): 768–772.
- Bonde J, Bottari F, Parvu V, et al. Bayesian analysis of baseline risk of CIN2 and ≥CIN3 by HPV genotype in a European referral cohort. Int J Cancer. 2019; 145(4): 1033–1041.
- Bottari F, Iacobone AD, Boveri S, et al. Onclarity Human Papillomavirus Extended Genotyping in the Management of Cervical Intraepithelial Neoplasia 2+ Lesions. J Low Genit Tract Dis. 2019; 23(1): 39–42.
- Nakamura M, Nakade K, Orisaka S, et al. Comparison Study of BD Onclarity HPV With digene HC2 High-Risk HPV DNA Test and Roche Cobas 4800 HPV for Detecting High-Risk Human Papillomavirus in Japan. Am J Clin Pathol. 2019; 151(3): 263–269.
- Volesky KD, Magnan S, Mayrand MH, et al. Clinical Performance of the BD Onclarity Extended Genotyping Assay for the Management of Women Positive for Human Papillomavirus in Cervical Cancer Screening. Cancer Epidemiol Biomarkers Prev. 2022; 31(4): 851–857.
- Wong OGW, Ng IFY, Tsun OKL, et al. Machine Learning Interpretation of Extended Human Papillomavirus Genotyping by Onclarity in an Asian Cervical Cancer Screening Population. J Clin Microbiol. 2019; 57(12).
- Elfgren K, Elfström KM, Naucler P, et al. Management of women with human papillomavirus persistence: long-term follow-up of a randomized clinical trial. Am J Obstet Gynecol. 2017; 216(3): 264.e1–264.e7.
