Assunção Larissa Dias, Discacciati Michelle Garcia, da Silva Andressa Germano, Yoshida Adriana, Vale Diama Bhadra, Teixeira Julio Cesar
Department of Obstetrics and Gynecology, University of Campinas (UNICAMP), Campinas, São Paulo, Brazil.
Department of Pathology, Federal University of Sao Paulo, Sao Paulo, Brazil.
Cytopathology. 2025 Nov;36(6):552-557. doi: 10.1111/cyt.13495. Epub 2025 Apr 23.
Cervical cancer remains a significant global health concern, primarily associated with persistent infections by high-risk human papillomavirus (hr-HPV). As screening programmes evolve from traditional cytology to DNA-HPV testing, the need for a liquid medium that maintains the integrity of cervical samples for biomolecular analysis and cytology becomes critical.
This study evaluated the performance of the candidate liquid preservation medium (PM) Cytoliq for cervical samples intended for DNA-HPV testing and liquid-based cytology (LBC), in comparison with the reference PM, PreservCyt-ThinPrep. A total of 112 women aged 18-64 years underwent routine gynaecological examinations, with paired cervical samples preserved in both PM for HPV testing and genotyping (Cobas HPV test), and LBC. The study aimed for a sensitivity greater than 90% in detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+), moderate to high agreement in HPV testing results (Kappa index > 0.70) and adequate performance in LBC.
The candidate PM exhibited non-inferior performance relative to the reference PM. DNA-HPV testing showed a 94.5% agreement rate (Kappa = 0.88) and a sensitivity of 92.9% for CIN2+ detection. Additionally, the candidate PM performed well in LBC smear production, with no significant differences in cytological diagnoses. The agreement in LBC diagnoses was 94.0% (Kappa = 0.79) with the ThinPrep processor and 91.8% (Kappa = 0.63) with the Cytoliq processor.
The Cytoliq PM demonstrated comparable efficacy to the reference for DNA-HPV testing and LBC, supporting its potential as an alternative preservation medium in cervical cancer screening programmes.
宫颈癌仍然是一个重大的全球健康问题，主要与高危型人乳头瘤病毒（hr-HPV）的持续感染有关。随着筛查计划从传统细胞学检测向DNA-HPV检测发展，对于一种能维持宫颈样本完整性以进行生物分子分析和细胞学检查的液体培养基的需求变得至关重要。
本研究评估了候选液体保存培养基（PM）Cytoliq用于旨在进行DNA-HPV检测和液基细胞学检查（LBC）的宫颈样本的性能，并与参考PM PreservCyt-ThinPrep进行比较。共有112名年龄在18至64岁的女性接受了常规妇科检查，成对的宫颈样本分别保存在两种PM中用于HPV检测和基因分型（Cobas HPV检测）以及LBC。该研究旨在检测宫颈上皮内瘤变2级或更严重病变（CIN2+）时的敏感性大于90%，HPV检测结果具有中度至高一致性（Kappa指数>0.70），并且在LBC方面表现良好。
候选PM相对于参考PM表现出非劣效性能。DNA-HPV检测显示一致性率为94.5%（Kappa = 0.88），检测CIN2+的敏感性为92.9%。此外，候选PM在LBC涂片制作方面表现良好，细胞学诊断无显著差异。LBC诊断与ThinPrep处理器的一致性为94.0%（Kappa = 0.79），与Cytoliq处理器的一致性为91.8%（Kappa = 0.63）。
Cytoliq PM在DNA-HPV检测和LBC方面显示出与参考物相当的功效，支持其作为宫颈癌筛查计划中替代保存培养基的潜力。
