Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening

• Published in: Cancer epidemiology, biomarkers & prevention Vol. 29; no. 12; pp. 2651 - 2661
• Main Authors: Rohner, Eliane, Edelman, Claire, Sanusi, Busola, Schmitt, John W, Baker, Anna, Chesko, Kirsty, Faherty, Brian, Gregory, Sean M, Romocki, LaHoma S, Sivaraman, Vijay, Nelson, Julie A E, O'Connor, Siobhan, Hudgens, Michael G, Knittel, Andrea K, Rahangdale, Lisa, Smith, Jennifer S
• Format: Journal Article
• Language: English
• Published: United States 01.12.2020
• Subjects: Adult; Aged; Early Detection of Cancer; Female; Genotype; Human papillomavirus 16 - genetics; Humans; Middle Aged; Uterine Cervical Neoplasms - genetics; Uterine Cervical Neoplasms - virology
• ISSN: 1055-9965; 1538-7755
• DOI: 10.1158/1055-9965.EPI-20-0674

Primary high-risk human papillomavirus (hr-HPV) testing of self-collected cervico-vaginal swabs could increase cervical cancer screening coverage, although triage strategies are needed to reduce unnecessary colposcopies. We evaluated the use of extended hr-HPV genotyping of self-collected samples for cervical cancer screening. We recruited women ages 25-65 years at two colposcopy clinics in North Carolina between November 2016 and January 2019, and obtained self-collected cervico-vaginal samples, provider-collected cervical samples, and cervical biopsies from all enrolled women. Self- and provider-collected samples were tested for 14 hr-HPV genotypes using the Onclarity Assay (Becton Dickinson). We calculated hr-HPV genotype-specific prevalence and assessed agreement between results in self- and provider-collected samples. We ranked the hr-HPV genotypes according to their positive predictive value (PPV) for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or higher (CIN2+). A total of 314 women participated (median age, 36 years); 85 women (27%) had CIN2+. More women tested positive for any hr-HPV on self-collected (76%) than on provider-collected samples (70%; = 0.009) with type-specific agreement ranging from substantial to almost perfect. HPV-16 was the most common genotype in self-collected (27%) and provider-collected samples (20%), and HPV-16 prevalence was higher in self- than provider-collected samples ( < 0.001). In self- and provider-collected samples, HPV-16 had the highest PPV for CIN2+ detection. Overall sensitivity for CIN2+ detection was similar for both sample types, but the higher HPV-16 prevalence in self-collected samples could result in increased colposcopy referral rates. Additional molecular markers might be helpful to improve the triage of women who are hr-HPV positive on self-collected samples.