Cytopathology : official journal of the British Society for Clinical Cytology · 2025
Clinical Performance of a Liquid Preservation Medium for Cervicovaginal Samples in DNA-HPV Testing and Liquid-Based Cytology for Cervical Cancer Screening.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Assunção Larissa Dias, Discacciati Michelle Garcia, da Silva Andressa Germano, Yoshida Adriana, Vale Diama Bhadra, Teixeira Julio Cesar
Аннотация
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.
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.