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

• Published in: Infectious agents and cancer Vol. 15; no. 1; p. 64
• Main Authors: Goldstein, Andrew, Lei, Yang, Goldstein, Lena, Goldstein, Amelia, Bai, Qiao Xu, Felix, Juan, Lipson, Roberta, Demarco, Maria, Schiffman, Mark, Egemen, Didem, Desai, Kanan T, Bedell, Sarah, Gersten, Janet, Goldstein, Gail, O'Keefe, Karen, O'Keefe, Casey, O'Keefe, Tierney, Sebag, Cathy, Lobel, Lior, Zhao, Anna, Lu, Yan Ling
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 22.10.2020; BioMed Central; BMC
• Subjects: Ablation; Ablation (Surgery); Biopsy; Breast cancer; Cancer prevention; Cancer research; Cancer screening; Cellular biology; Cervical cancer; Cervix; Colposcopy; Consent; Detection equipment; Diagnosis; Ethnicity; Histology; Human papillomavirus; Lesions; Medical screening; Minority & ethnic groups; Mortality; Papillomavirus infections; Population; Rural areas; Sampling; Vaccination; Vagina; Women's health; Womens health; China; Inner Mongolia China; California
• ISSN: 1750-9378; 1750-9378
• DOI: 10.1186/s13027-020-00329-0

Rapid, high-volume screening programs are needed as part of cervical cancer prevention in China. 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. 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). 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.