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