目前已有数种经验证的HPV检测方法。然而，为了筛查方案的选择，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。我们研究的目标是评估HPV mRNA和HPV DNA测试的性能，包括部分基因分型，用于常规宫颈筛查。作为CERVIVA HPV初筛研究的一部分，我们对10,150名妇女的ThinPrep样本进行了Aptima HPV检测和Cobas 4800 HPV检测，以检测HPV mRNA和HPV DNA。对于HPV mRNA检测阳性的妇女还进一步进行了Aptima基因分型检测，以检测HPV 16/18/45基因型。我们收集了基线细胞学和前瞻性随访数据。在至今为止的42个月内，我们考察了这两种测试的性能。HPV mRNA检测在CIN2+（93.2% [92.4-93.9]对92.8% [92.0-93.6]）和CIN3+（94.6% [93.8-95.3]对94.6% [93.8-95.3]）的检出方面表现出与HPV DNA检测等效的敏感性。与HPV DNA相比，HPV mRNA检测对于CIN2+（84.0% [83.5-84.5]对80.8% [80.2-81.4]）和CIN3+（88.44% [88.2-88.6]对85.62% [85.4-85.9]）的检出具有显著较高的特异性。在3年（42个月）的时间内，HPV阴性妇女中的CIN2+和CIN3+的比例在RNA（0.20%和0.10%）和DNA（0.22%和0.11%）两种检测方法中相当。基因分型数据在两种试验平台上是可比较的。在HPV初筛的背景下，与DNA测试相比，HPV mRNA测试有潜力在12个月时减少追踪测试和随访测试，并且在CIN2+和CIN3+的检出方面没有显著差异。 © 2023 The Authors. International Journal of Cancer 由John Wiley & Sons Ltd代表UICC出版。

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+.© 2023 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.