Triage Value of Cervical Exfoliated Cell DNA Ploidy Analysis in Cervical High-Risk Human Papillomavirus–Positive Women

Abstract

Objective This study aimed to investigate the triage value obtained in DNA ploidy analysis of cervical exfoliated cells in women with high-risk human papillomavirus (HR-HPV)-positive status in the primary screening of cervical cancer. Methods We selected 3,000 HR-HPV–positive women for cervical exfoliated cell sampling and conducted DNA ploidy analysis, liquid-based cytology (LBC), colposcopy, and cervical biopsy. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of high-grade squamous intraepithelial lesion (HSIL)-positive detection between DNA ploidy analysis and LBC were compared according to histopathology diagnosis as the golden criteria, and the efficacy of predicting HSIL-positive immediate risk was evaluated. Results A total of 2,892 HR-HPV–positive women were enrolled in the investigation. For HSIL+ women, the DNA ploidy group showed a significantly higher sensitivity (CIN2+: 79.21% vs 65.35%, p = .022; CIN3+: 81.48% vs 70.37%, p = .013), lower specificity (CIN2+: 85.00% vs 96.59%, p < .001; CIN3+: 84.14% vs 93.41%, p < .001), and lower PPV (CIN2+: 16.23% vs 29.33%, p = .001; CIN3+: 8.92% vs 16.89%, p = .002) compared with the LBC group, whereas the NPV showed no significant difference. Compared with LBC alone in diagnosing HSIL, DNA ploidy combined with LBC showed higher specificity (CIN2+: 99.21% vs 96.59%, p = .003; CIN3+: 96.48% vs 93.41%, p < .001) and higher PPV (CIN2+: 41.35% vs 29.33%, p = .022; CIN3+: 24.81% vs 16.89%, p = .028), whereas no significant difference was observed in the sensitivity (CIN2+: 54.46% vs 65.35%, p = .063; CIN3+: 61.11% vs 70.37%, p = .221) and NPV (p > .05). Among the HR-HPV–positive women positive for DNA ploidy, the imminent risk of CIN2+ and CIN3+ were 15.62% and 8.92%, respectively, above the threshold for the colposcopy positive rate. Among the positive cases both for DNA ploidy and the LBC result of negative for intraepithelial lesion or malignancy, the immediate risk of CIN3+ was 3.31%, below the threshold for colposcopy positive rate. Besides, for women with LBC result of ASC-US and above, the immediate risk of CIN3+ was greater than 4%. Conclusions The DNA ploidy analysis can be used as an effective triage method for HR-HPV–positive women during the primary screening of cervical cancer, although it can provide higher specificity when combined with LBC and reduce the referral rate for colposcopy.