Evaluation of an isothermal amplification HPV detection assay for primary cervical cancer screening

Infectious Agents and Cancer

Xianzhi Duan¹  Lihui Wei²  Xinfeng Qu³  Yan Liu⁴  M. Schiffman⁵  Hui Du⁶  Chun Wang⁶  Xia Huang⁶  Ruifang Wu⁶  Bin Shi⁷  J. L. Belinson⁸  Wei Zhang⁹ 

[1] Capital Medical University Beijing Tongren Hospital, Beijing, P. R. China;Department of Obstetrics and Gynecology, Peking University People’s Hospital, Beijing, P. R. China;Expert in Three Engineering Office, Shenzhen Maternal of Peking University Shenzhen Hospital, 518036, Shenzhen, China;Fudan University Huanshan Hospital, Shanghai, P. R. China;National Cancer Institute, Division of Epidemiology and Genetics, Bethesda, USA;Peking University Shenzhen Hospital, 518036, Shenzhen, P. R. China;Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, P. R. China;The second Hospital of Hebei Medical University, Shijiazhuang, P. R. China;Women’s Health Institute, Cleveland Clinic, Cleveland, OH, USA;PPreventive Oncology International, Inc., Shaker Heights, USA;Wuhan University Zhongnan Hospital, Wuhan, P. R. China;

关键词: AmpFire assay, Human papillomavirus;    Self-collection;    Clinician-collection;    Isothermal amplification;   

DOI  :  10.1186/s13027-020-00328-1

来源: Springer

【 摘 要 】

ObjectiveThe aim of this research was to evaluate independently the performance of a new isothermal amplification assay for cervical cancer screening compared to two previously validated PCR-based assays and histologic endpoints.MethodsThis is a sub-study from the Chinese multi-center screening trial (CHIMUST). The self-collected and clinician-collected specimens stored in PreservCyt at − 4 °C from 6042 women with complete data were tested with the AmpFire assay. These specimens had been previously tested with Cobas and SeqHPV assays. In the primary study all patients with an abnormal test were referred to colposcopy where all had directed and/or random biopsies plus ECC. No additional patients were called back based on the AmpFire results.Results6042/6619 women had complete data (mean age 44.1). There were 57 cases of CIN 2, 35 cases of CIN 3 and 2 cancers. The sensitivity for CIN2+ and CIN3+ were similar among the three assays (both direct and self-collected). For the specificities in all categories (CIN2+/CIN3+ and self and direct collection), isothermal amplification assay was either equal to or more specific than Cobas but consistently less specific than SeqHPV.ConclusionThe AmpFire HPV assay showed similar sensitivity to Cobas and SeqHPV for CIN2+ and CIN3+ on both self and clinician-collections (P>0.05), with good specificity. The speed, low cost, and simplicity of this assay will make it particularly suited for low and middle resource settings. Its accuracy with self-collection makes it applicable for mass screening programs.

【 授权许可】

CC BY