White Christine, Reynolds Stephen, Murphy Katherine, Keegan Helen, Naik Padma, O'Brien Roisin, Pilkington Loretto, Sharkey Ochoa Imogen, Glesson Grainne, Russell Noirin, Nuttall David, Tewari Prerna, Wright Fiona, O'Toole Sharon, Sharp Linda, Flannelly Grainne, O'Leary John J, Martin Cara M
TCD CERVIVA Molecular Pathology Laboratory, Trinity College Dublin, Dublin, Ireland.
Discipline of Histopathology, St. James' University Hospital, Trinity College Dublin, Dublin, Ireland.
Int J Cancer. 2024 Jan 1;154(1):53-64. doi: 10.1002/ijc.34685. Epub 2023 Aug 26.
There are currently several validated HPV tests. However, longitudinal data which spans appropriate age ranges, as well as evaluation of potential screening algorithms are necessary for screening programmes choice of test. The objective of our study was to evaluate the performance of HPV mRNA and HPV DNA testing, including partial genotyping, in routine cervical screening. As part of the CERVIVA HPV Primary Screening Study, ThinPrep samples from 10 150 women were tested for HPV mRNA using the Aptima HPV assay and HPV DNA using the Cobas 4800 HPV test. HPV mRNA-positive women were further assessed with the Aptima genotyping assay for HPV 16/18/45. Baseline cytology and prospective follow-up data were collected. The performance of the two tests was examined over 42 months (to date). HPV mRNA demonstrated equivalent sensitivity to HPV DNA testing for detection of CIN2+ (93.2% [92.4-93.9] vs 92.8% [92.0-93.6], respectively) and CIN3+ (94.6% [93.8-95.3] vs 94.6% [93.8-95.3]). HPV mRNA testing had significantly higher specificity compared to HPV DNA for detection of CIN2+ (84.0% [83.5-84.5] vs 80.8% [80.2-81.4], respectively) and CIN3+ (88.44% [88.2-88.6] vs 85.62 [85.4-85.9]). The proportion of CIN2+ and CIN3+, over 3 years (42 months), in HPV-negative women was comparable for both RNA (0.20% and 0.10%) and DNA (0.22% and 0.11%). Genotyping data was comparable across both assay platforms. In the context of HPV primary screening HPV mRNA testing has potential to reduce triage tests and follow-up tests at 12 months compared to DNA testing, with no significant difference in detection of CIN2+ and CIN3+.
目前有几种经过验证的HPV检测方法。然而，对于筛查项目检测方法的选择而言，需要涵盖适当年龄范围的纵向数据以及对潜在筛查算法的评估。我们研究的目的是评估HPV mRNA检测和HPV DNA检测（包括部分基因分型）在常规宫颈筛查中的性能。作为CERVIVA HPV初筛研究的一部分，使用Aptima HPV检测法对10150名女性的ThinPrep样本进行HPV mRNA检测，并使用Cobas 4800 HPV检测法进行HPV DNA检测。对HPV mRNA呈阳性的女性进一步使用Aptima基因分型检测法检测HPV 16/18/45。收集了基线细胞学和前瞻性随访数据。在42个月（截至目前）的时间里对这两种检测方法的性能进行了检查。HPV mRNA检测在检测CIN2+（分别为93.2% [92.4 - 93.9] 与92.8% [92.0 - 93.6]）和CIN3+（分别为94.6% [93.8 - 95.3] 与94.6% [93.8 - 95.3]）方面表现出与HPV DNA检测相当的敏感性。在检测CIN2+（分别为84.0% [83.5 - 84.5] 与80.8% [80.2 - 81.4]）和CIN3+（分别为88.44% [88.2 - 88.6] 与85.62 [85.4 - 85.9]）方面，HPV mRNA检测的特异性显著高于HPV DNA检测。在HPV阴性女性中，3年（42个月）内CIN2+和CIN3+的比例在RNA检测（分别为0.20%和0.10%）和DNA检测（分别为0.22%和0.11%）中相当。两种检测平台的基因分型数据相当。在HPV初筛的背景下，与DNA检测相比，HPV mRNA检测有可能减少12个月时的分流检测和随访检测，在检测CIN2+和CIN3+方面无显著差异。
