Inturrisi Federica, de Sanjosé Silvia, Desai Kanan T, Dagnall Casey, Egemen Didem, Befano Brian, Rodriguez Ana Cecilia, Jeronimo Jose A, Zuna Rosemary E, Hoffman Amanda, Farhat Nozzari Sepideh, Walker Joan L, Perkins Rebecca B, Wentzensen Nicolas, Palefsky Joel M, Schiffman Mark
Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland, USA.
ISGlobal, Barcelona, Spain.
Int J Cancer. 2024 Jan 15;154(2):241-250. doi: 10.1002/ijc.34698. Epub 2023 Sep 29.
The World Health Organization recommends human papillomavirus (HPV) testing for cervical screening. Extended genotyping can identify the highest-risk HPV-positive women. An inexpensive, rapid, mobile isothermal amplification assay (ScreenFire HPV RS test) was recently redesigned to yield four channels ordered by cancer risk (ie, hierarchical approach): HPV16, HPV18/45, HPV31/33/35/52/58 and HPV39/51/56/59/68. Stored specimens from 2076 women (mean age 30.9) enrolled in a colposcopy clinic, with high HPV prevalence, were tested with ScreenFire. We calculated hierarchical channel positivity and non-hierarchical channel and type positivity, according to histologic diagnosis (256 cancer, 350 cervical intraepithelial neoplasia [CIN]3, 409 CIN2, 1020 < CIN2) and known virologic reference results (Linear Array and TypeSeq). Additionally, we analyzed ScreenFire time-to-positive up to 60 min by channel and histology. Overall clinical sensitivity for CIN3+ was 94.7% (95% confidence interval 92.6-96.4), similar to Linear Array (92.3, 89.7-94.3) and TypeSeq (96.0, 93.9-97.6). Sensitivity was high for all types and channels. The hierarchical approach was well in line with HPV typing and histologic diagnosis, prioritizing higher risk women having HPV16 and precancer. For HPV16, time-to-positive was shorter in women with precancer. ScreenFire showed excellent agreement with research reference typing tests and detection of CIN2+. Risk-based type results could help guide clinical management of HPV-positive women. Time-to-positive combined with genotyping might be useful. ScreenFire is rapid, mobile, relatively inexpensive and designed for implementation of HPV-based screening and management, including in lower-resource settings. Further validation in screening by self-sampling and practical effectiveness merit evaluation.
世界卫生组织建议采用人乳头瘤病毒（HPV）检测进行宫颈癌筛查。扩展基因分型可识别出HPV阳性且风险最高的女性。最近对一种廉价、快速、可移动的等温扩增检测方法（ScreenFire HPV RS检测）进行了重新设计，以产生按癌症风险排序的四个通道（即分层方法）：HPV16、HPV18/45、HPV31/33/35/52/58和HPV39/51/56/59/68。对一家阴道镜诊所中2076名女性（平均年龄30.9岁）的储存样本进行了ScreenFire检测，这些女性的HPV感染率较高。我们根据组织学诊断（256例癌症、350例宫颈上皮内瘤变[CIN]3、409例CIN2、1020例<CIN2）和已知的病毒学参考结果（线性阵列和TypeSeq）计算了分层通道阳性率以及非分层通道和类型阳性率。此外，我们分析了ScreenFire在长达60分钟内按通道和组织学分类的阳性时间。CIN3+的总体临床敏感性为94.7%（95%置信区间92.6 - 96.4），与线性阵列（92.3，89.7 - 94.3）和TypeSeq（96.0，93.9 - 97.6）相似。所有类型和通道的敏感性都很高。分层方法与HPV分型和组织学诊断非常吻合，将感染HPV16和癌前病变的高风险女性列为优先考虑对象。对于HPV16，癌前病变女性的阳性时间更短。ScreenFire与研究参考分型检测以及CIN2+的检测结果高度一致。基于风险的分型结果有助于指导HPV阳性女性的临床管理。阳性时间与基因分型相结合可能会很有用。ScreenFire快速、可移动、相对廉价，专为基于HPV的筛查和管理而设计，包括在资源较少的环境中。通过自我采样进行筛查的进一步验证以及实际效果值得评估。
