Evidence for triaging HPV-positive women using viral load: data from two large cohort-screening projects in different regions of China
To evaluate the effectiveness of viral load (VL)-based triage strategies for human papillomavirus (HPV)-positive women, utilizing data from two large cohort screening studies. We analyzed 1656 HPV-positive cases identified among 25,419 screening participants. Collected data included HPV testing, cytology, and pathologically confirmed diagnoses. VL-based triage strategies were compared to a guideline-recommended cytology-based triage. The cycle threshold (Ct) value, representing HPV VL, was used for triage, with the 75th percentile of Ct values established as the cut-off. Outcomes were assessed for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3+. The mean participant age was 43 ± 7.99 years. Two triage strategies were compared: (1) HPV-16/18 and other types with Ct ≤ the 75th percentile cut-off (higher viral load), and (2) HPV-16/18 & other types with cytology (referring those with ≥ atypical squamous cells of undetermined significance [ASCUS] for colposcopy). The VL-based strategy demonstrated higher sensitivity than the cytology-based strategy for detecting CIN2+ (91.52% vs. 85.27%, p = 0.016) and was comparable for detecting CIN3+ (95.60% vs. 96.70%, p = 1.000). Similarly, the strategy using HPV-16/18 with Ct ≤ 75th & other types with Ct ≤75th was also comparable to the cytology-based approach for detecting both CIN2+ (87.05% vs. 85.27%, p = 0.636) and CIN3+ (95.60% vs. 96.70%, p = 1.000). Viral load-based triage effectively identifies cervical precancer/ cancer in HPV-positive individuals without cytology, allows single-sample collection, reduces multiple visits, and may be most useful where cytology is unavailable or unreliable-acknowledging an increased colposcopy referral.