Zhang Wei, Du Hui, Huang Xia, Wang Chun, Duan Xianzhi, Liu Yan, Shi Bin, Zhang Wei, Qu Xinfeng, Wei Lihui, Schiffman M, Belinson J L, Wu Ruifang
Peking University Shenzhen Hospital, Shenzhen, 518036 P. R. China.
Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, P. R. China.
Infect Agent Cancer. 2020 Oct 23;15:65. doi: 10.1186/s13027-020-00328-1. eCollection 2020.
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.
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.
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.
The AmpFire HPV assay showed similar sensitivity to Cobas and SeqHPV for CIN2+ and CIN3+ on both self and clinician-collections (>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.
本研究旨在独立评估一种用于宫颈癌筛查的新型等温扩增检测方法与两种先前验证的基于聚合酶链反应（PCR）的检测方法及组织学终点相比的性能。
这是一项来自中国多中心筛查试验（CHIMUST）的子研究。对6042名拥有完整数据的女性在-4°C下保存在PreservCyt中的自行采集和临床医生采集的样本进行AmpFire检测。这些样本之前已用Cobas和SeqHPV检测方法进行过检测。在初步研究中，所有检测结果异常的患者均被转诊至阴道镜检查，在那里所有患者均进行了定向和/或随机活检加宫颈管搔刮术。没有根据AmpFire检测结果召回额外的患者。
6042/6619名女性拥有完整数据（平均年龄44.1岁）。有57例宫颈上皮内瘤变2级（CIN 2）、35例CIN 3和2例癌症。在三种检测方法（自行采集和临床医生采集）中，CIN2+和CIN3+的敏感性相似。对于所有类别（CIN2+/CIN3+以及自行采集和临床医生采集）的特异性，等温扩增检测方法要么与Cobas相等，要么比其更具特异性，但始终比SeqHPV的特异性低。
AmpFire人乳头瘤病毒（HPV）检测方法在自行采集和临床医生采集样本时，对CIN2+和CIN3+的敏感性与Cobas和SeqHPV相似（>0.05），具有良好的特异性。该检测方法的速度、低成本和简便性使其特别适用于中低收入资源环境。其自行采集样本时的准确性使其适用于大规模筛查项目。
