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

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.

Redesign of a rapid, low‐cost HPV typing assay to support risk‐based cervical screening and management

“…The test does require basic pipetting skills. 22,23 The test reagents are stable at room temperature for 2 weeks, at 4 C for up to a month and at À20 C for a year. In addition, the test platform is portable and the same platform can test for other sexually transmitted infections and Coronavirus Disease of 2019 (COVID-19).…”

“…In addition, the test platform is portable and the same platform can test for other sexually transmitted infections and Coronavirus Disease of 2019 (COVID-19). 22,23 The assay could help to address an identified public health need.…”

“…An isothermal amplification technology-based AmpFire HPV assay (Atila Biosystems, Inc., Mountain View, California) shows promise in this regard. 22 The assay in its two current formats offers (a) multiplex detection in a single tube of 15 HPV types (ie, including HPV53 and HPV66) with separate detection of types 16/18 or (b) full genotyping of 15 individual types in four tubes. The assays are Conformité Européenne (CE) marked 23 and previously demonstrated to have satisfactory performance in analytical 24 and clinical validation.…”

The Application of Artificial Intelligence-Assisted Colposcopy in a Tertiary Care Hospital within a Cervical Pathology Diagnostic Unit

“…The acquired images/colpograms were assessed using an artificial intelligence-based algorithm called Visualcheck TM . The algorithm used is a built-in feature of the colposcope-like instrument registered within the European Union under the brand name EVA System [ 24 , 25 ].…”

Self-Sampling Devices for HPV Testing

“…In a before-and-after study of rates of cervical cancer screening among transmasculine or non-binary patients in New York City, providers offered a self-swab to patients who declined a speculum exam. 54 Prior to the introduction of self-collection, 25% of 121 identified transmasculine patients had cervical cancer screening documented on their records. After the switch to self-collection for high-risk HPV testing, there was a significant increase (51% of 193; P < 0.001) in patients who had a screening test documented in their medical record.…”