A rapid, high-volume cervical screening project using self-sampling and isothermal PCR HPV testing

• Main Authors: Andrew Goldstein, Yang Lei, Lena Goldstein, Amelia Goldstein, Qiao Xu Bai, Juan Felix, Roberta Lipson, Maria Demarco, Mark Schiffman, Didem Egemen, Kanan T. Desai, Sarah Bedell, Janet Gersten, Gail Goldstein, Karen O’Keefe, Casey O’Keefe, Tierney O’Keefe, Cathy Sebag, Lior Lobel, Anna Zhao, Yan Ling Lu
• Format: Article
• Language: English
• Published: BMC 2020-10-01
• Series: Infectious Agents and Cancer
• Online Access: http://link.springer.com/article/10.1186/s13027-020-00329-0

Abstract Objective Rapid, high-volume screening programs are needed as part of cervical cancer prevention in China. Methods In a 5-day screening project in Inner Mongolia, 3345 women volunteered following a community awareness campaign, and self-swabbed to permit rapid HPV testing. Two AmpFire™ HPV detection systems (Atila Biosystems) were sufficient to provide pooled 15-HPV type data within an hour. HPV+ patients had same-day digital colposcopy (DC) performed by 1 of 6 physicians, using the EVA™ system (MobileODT). Digital images were obtained and, after biopsy of suspected lesions for later confirmatory diagnosis, women were treated immediately based on colposcopic impression. Suspected low- grade lesions were offered treatment with thermal ablation (Wisap), and suspected high-grade lesions were treated with LLETZ. Results Of 3345 women screened, 624 (18.7%) were HPV+. Of these, 88.5% HPV+ women underwent same-day colposcopy and 78 were treated. Later consensus histology results obtained on 197 women indicated 20 CIN2+, of whom 15 were detected and treated/referred at screening (10 by thermal ablation, 4 by LLETZ, 1 by referral). Conclusions Global control of cervical cancer will require both vaccination and screening of a huge number of women. This study illustrates a cervical screening strategy that can be used to screen-and-treat large numbers of women. HPV self-sampling facilitates high-volume screening. Specimens can be tested rapidly, promoting minimal loss-to-follow-up. Specifically, the AmpFire™ system used in this study is highly portable, simple, rapid (92 specimens per 65 min per unit), and economical. Visual triage can be performed on HPV+ women with a portable digital colposcope that provides magnification, lighting, and a recorded image. Diagnosis and appropriate treatment remain the most subjective elements. The digital image is under study for deep-learning based automated evaluation that could assist the management decision, either by itself or combined with HPV typing.