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

Infectious Agents and Cancer - 2020
Wei Zhang1, Hui Du1, Xia Huang1, Chun Wang1, Xiaohui Duan2, Yan Liu3, Bin Shu4, Xinfeng Qu5, Lihui Wei6, Mark Schiffman7, Jerome L. Belinson8, Ruifang Wu1
1Peking University Shenzhen Hospital, Shenzhen, P. R. China
2Capital Medical University Beijing Tongren Hospital, Beijing, P. R. China
3Fudan University Huanshan Hospital, Shanghai, P. R. China.
4The Second Hospital of Hebei Medical University, Shijiazhuang, P.R. China
5Expert in Three Engineering Office, Shenzhen Maternal of Peking University Shenzhen Hospital, Shenzhen, 518036 China.
6Department of Obstetrics and Gynecology, Peking University People’s Hospital, Beijing, P. R. China
7National Cancer Institute, Division of Epidemiology and Genetics, Bethesda, USA.
8Women’s Health Institute, Cleveland Clinic, Cleveland, USA

Tóm tắt

Abstract Objective The 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. Methods This 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. Results 6042/6619 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. Conclusion The 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.

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