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

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收录情况： ◇ SCIE

作者：

机构： [1]Peking University Shenzhen Hospital, Shenzhen 518036, P. R. China [2]Shenzhen Key Laboratory on Technology for Early Diagnosis of MajorGynecological diseases, Shenzhen, P. R. China [3]Capital Medical UniversityBeijing Tongren Hospital, Beijing, P. R. China [4]Fudan University HuanshanHospital, Shanghai, P. R. China [5]The second Hospital of Hebei MedicalUniversity, Shijiazhuang, P. R. China [6]Wuhan University Zhongnan Hospital,Wuhan, P. R. China [7]Expert in Three Engineering Office, Shenzhen Maternalof Peking University Shenzhen Hospital, Shenzhen 518036, China [8]Department of Obstetrics and Gynecology, Peking University People’sHospital, Beijing, P. R. China [9]National Cancer Institute, Division ofEpidemiology and Genetics, Bethesda, USA [10]Women’s Health Institute,Cleveland Clinic, Cleveland, OH, USA [11]PPreventive Oncology International,Inc., Shaker Heights, USA.

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

摘要：

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. © 2020, The Author(s).

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基金编号： 2018

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出版当年[2019]版：

大类 | 4 区医学

小类 | 4 区免疫学 4 区肿瘤学

最新[2025]版：

大类 | 3 区医学

小类 | 3 区免疫学 4 区肿瘤学

JCR分区：

出版当年[2018]版：

Q3 ONCOLOGY Q3 IMMUNOLOGY

最新[2023]版：

Q2 ONCOLOGY Q3 IMMUNOLOGY

影响因子： 3.1 最新[2023版] 3.3 最新五年平均 2.47 出版当年[2018版] 2.36 出版当年五年平均 2.123 出版前一年[2017版] 2.74 出版后一年[2019版]

第一作者：

第一作者机构： [1]Peking University Shenzhen Hospital, Shenzhen 518036, P. R. China [2]Shenzhen Key Laboratory on Technology for Early Diagnosis of MajorGynecological diseases, Shenzhen, P. R. China

共同第一作者：

通讯作者：

通讯机构： [1]Peking University Shenzhen Hospital, Shenzhen 518036, P. R. China [2]Shenzhen Key Laboratory on Technology for Early Diagnosis of MajorGynecological diseases, Shenzhen, P. R. China [10]Women’s Health Institute,Cleveland Clinic, Cleveland, OH, USA [11]PPreventive Oncology International,Inc., Shaker Heights, USA.

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

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