Clinical performance of a genotyping assay based on a hybrid capture technique in cervical cancer screening in China: a prospective population-based multicentre cohort study
We aimed to assess the clinical performance of DH3, a hybrid capture assay that separately detects human papillomavirus (HPV) 16/18 and 12 other HPV types, for primary screening for cervical cancer in the general population, following Chinese guidelines. A total of 9379 eligible women aged 21 to 64 years from three centres underwent baseline screening with DH3 and liquid-based cytology (LBC), and were subsequently followed for 3 years. The diagnostic performance of HPV testing (DH3) and LBC-including sensitivity, specificity, positive predictive value (absolute risk), and negative predictive value-was evaluated for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) Lesions. At baseline, 146 (1.56%) participants were identified with CIN2+ lesions. Compared with LBC with reflex high-risk HPV (HR-HPV), primary HR-HPV with reflex LBC showed a significantly higher sensitivity (95.89% [95% CI: 91.33%-98.10%] vs. 84.93% [95% CI: 78.24%-89.83%], P Our study indicates that DH3 exhibits dependable clinical performance in cervical screening. The validated HPV test is expected to enhance the quality of population-based screening.