Sørbye S, Falang B M, Antonsen M, Mortensen E
Department of Clinical Pathology, University Hospital of North Norway, 9006 Tromsø, Norway.
PreTect AS, 3490 Klokkarstua, Norway.
Pathogens. 2025 Jul 30;14(8):749. doi: 10.3390/pathogens14080749.
Effective triage of women testing positive for high-risk HPV DNA is essential to reduce unnecessary colposcopies while preserving cancer prevention. Cytology, the current standard, has limited specificity and reproducibility. The genotype-specific 7-type HPV E6/E7 mRNA test (PreTect HPV-Proofer'7), targeting HPV types 16, 18, 31, 33, 45, 52, and 58, detects transcriptionally active infections and may enhance risk stratification.
Between 2019 and 2023, 34,721 women aged 25-69 underwent primary HPV DNA screening with the Cobas 4800 assay at the University Hospital of North Norway, within the national screening program. Of these, 1896 HPV DNA-positive women were triaged with liquid-based cytology with atypical squamous cells of undetermined significance or worse (≥ASC-US) and the 7-type HPV mRNA test. Histological outcomes were followed through October 2024. Diagnostic performance for CIN2+ was evaluated overall and by genotype.
CIN2+ prevalence was 13.3%. The mRNA test reduced test positivity from 50.3% to 33.4% while maintaining comparable sensitivity (70.6% vs. 72.2%) and improving specificity (72.3% vs. 53.0%) and PPV (28.1% vs. 19.1%). Genotype-specific PPVs were highest for HPV16 mRNA (47.7%), followed by HPV33 (39.2%) and HPV31 (32.2%), all exceeding corresponding DNA-based estimates.
Genotype-specific HPV mRNA triage offers superior risk discrimination compared to cytology, supporting more targeted, efficient, and accessible cervical cancer screening.
对高危型人乳头瘤病毒（HPV）DNA检测呈阳性的女性进行有效的分流，对于减少不必要的阴道镜检查同时保持癌症预防效果至关重要。作为当前标准的细胞学检查，其特异性和可重复性有限。针对16、18、31、33、45、52和58型HPV的基因型特异性7型HPV E6/E7 mRNA检测（PreTect HPV-Proofer'7）可检测转录活跃的感染，并可能增强风险分层。
2019年至2023年期间，在挪威北部大学医院的国家筛查项目中，34721名年龄在25至69岁之间的女性接受了Cobas 4800检测法进行的原发性HPV DNA筛查。其中，1896名HPV DNA呈阳性的女性接受了液基细胞学检查，结果为意义不明确的非典型鳞状细胞或更严重情况（≥ASC-US），并进行了7型HPV mRNA检测。对组织学结果进行随访至2024年10月。总体及按基因型评估CIN2+的诊断性能。
CIN2+患病率为13.3%。mRNA检测将检测阳性率从50.3%降至33.4%，同时保持了相当的敏感性（70.6%对72.2%），提高了特异性（72.3%对53.0%）和阳性预测值（PPV，28.1%对19.1%）。HPV16 mRNA的基因型特异性PPV最高（47.7%），其次是HPV33（39.2%）和HPV31（32.2%），均超过了相应的基于DNA的估计值。
与细胞学检查相比，基因型特异性HPV mRNA分流提供了更好的风险辨别能力，支持更具针对性、高效且可及的宫颈癌筛查。
