Clinical Performance of a Liquid Preservation Medium for Cervicovaginal Samples in DNA-HPV Testing and Liquid-Based Cytology for Cervical Cancer Screening

IF 1.1 4区医学 Q4 CELL BIOLOGY

Cytopathology Pub Date : 2025-04-23 DOI:10.1111/cyt.13495

Larissa Dias Assunção, Michelle Garcia Discacciati, Andressa Germano da Silva, Adriana Yoshida, Diama Bhadra Vale, Julio Cesar Teixeira

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引用次数: 0

Abstract

Introduction

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.

Methods

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.

Results

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.

Conclusion

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.

Abstract Image

查看原文本刊更多论文

宫颈阴道样本液体保存介质在DNA-HPV检测和宫颈癌筛查中的临床表现。

宫颈癌仍然是一个重要的全球健康问题，主要与高危人乳头瘤病毒（hr-HPV）的持续感染有关。随着筛查计划从传统细胞学发展到DNA-HPV检测，需要一种液体培养基来保持宫颈样本的完整性，以进行生物分子分析和细胞学分析变得至关重要。方法：本研究评估了用于DNA-HPV检测和液体细胞学（LBC）的宫颈样本的候选液体保存介质（PM） Cytoliq的性能，并与参考PM PreservCyt-ThinPrep进行比较。共有112名年龄在18-64岁的女性接受了常规妇科检查，并在PM中保存了配对的宫颈样本，用于HPV检测和基因分型（Cobas HPV检测）和LBC。该研究旨在检测宫颈上皮内瘤变2级或更糟（CIN2+）的灵敏度大于90%，HPV检测结果（Kappa指数> 0.70）的一致性中等至高度，并在LBC中有足够的表现。结果：候选PM的表现不逊于参考PM。DNA-HPV检测的符合率为94.5% (Kappa = 0.88)， CIN2+检测的敏感性为92.9%。此外，候选PM在LBC涂片生产中表现良好，细胞学诊断无显着差异。ThinPrep处理器诊断LBC的一致性为94.0% (Kappa = 0.79)， Cytoliq处理器诊断LBC的一致性为91.8% （Kappa = 0.63）。结论：Cytoliq PM在DNA-HPV检测和LBC检测中表现出与参比相当的功效，支持其作为宫颈癌筛查计划的替代保存介质的潜力。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cytopathology 生物-病理学

CiteScore

2.30

自引率

15.40%

发文量

107

审稿时长

6-12 weeks

期刊介绍： The aim of Cytopathology is to publish articles relating to those aspects of cytology which will increase our knowledge and understanding of the aetiology, diagnosis and management of human disease. It contains original articles and critical reviews on all aspects of clinical cytology in its broadest sense, including: gynaecological and non-gynaecological cytology; fine needle aspiration and screening strategy. Cytopathology welcomes papers and articles on: ultrastructural, histochemical and immunocytochemical studies of the cell; quantitative cytology and DNA hybridization as applied to cytological material.