20.500.12556/RUL-166442 Clinically validated HPV assays offer comparable long-term safety in primary cervical cancer screening a 9-year follow-up of a population-based screening cohort Molecular testing for human papillomaviruses (HPV) is gradually replacing cytology in cervical cancer screening. In this longitudinal population-based cohort study, 4140 women 20 to 64 years old attending organized screening were tested at baseline by five different screening methods and followed for 9 years. To assess long-term safety, the cumulative risks of CIN2+/CIN3+ were estimated after a negative baseline result obtained by conventional cytology and four clinically validated HPV assays: Hybrid Capture 2 (hc2), RealTime High Risk HPV assay (RealTime), cobas 4800 HPV Test (cobas_4800), and Alinity m HR HPV (Alinity). HPV-negative women at baseline had a substantially lower risk for CIN2+ compared to those with normal baseline cytology: 0.84% (95% CI, 0.46–1.22), 0.90% (95% CI, 0.51–1.29), 0.78% (95% CI, 0.42–1.15), and 0.75% (95% CI, 0.39–1.11) for hc2, RealTime, cobas_4800, and Alinity, respectively, compared to 2.46% (95% CI, 1.88–3.03) for cytology. No differences were observed between HPV assays in longitudinal sensitivity (range: 86.21%–90.36%) and negative predictive values (range: 99.54%–99.70%) for CIN2+ in women ≥30 years, but were significantly different from cytology (p < .05). The 9-year cumulative risk of CIN2+ differed significantly between HPV genotypes, reaching 32.1% (95% CI, 14.5–46.1) for HPV16, 24.9% (95% CI, 4.7–40.8) for HPV18/45, 27.2% (95% CI, 14.6–37.8) for HPV31/33/35/52/58, and 8.1% (95% CI, 0.0–16.7) for HPV39/51/56/59. Four clinically validated HPV assays showed comparable safety and better assurance against precancerous lesions than cytology, but some important differences were identified in the performance characteristics of HPV assays impacting the referral rate. Information about the HPV genotype is valuable for guiding further clinical action in HPV-based screening programs. HPV testing cervical cancer cervical screening cytology testiranje na HPV rak materničnega vratu pregled materničnega vratu citologija true false true Angleški jezik Slovenski jezik Članek v reviji 2025-01-13 12:44:43 2025-01-13 12:44:48 2025-01-15 10:54:01 0000-00-00 00:00:00 2025 0 0 Str. 788-801 iss. 4 Vol. 156 2025 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 618.1-006 0020-7136 10.1002/ijc.35200 221889795 Intl_Journal_of_Cancer_-_2024_-_Ostrbenk_Valencak_-_Clinically_validated_HPV_assays_offer_comparable_long‐term_safety_in.pdf Intl_Journal_of_Cancer_-_2024_-_Ostrbenk_Valencak_-_Clinically_validated_HPV_assays_offer_comparable_long‐term_safety_in.pdf 1 5CFAD91C57CE6D0D48E03AD043FDEA66 5faa54c61c47a8f73609e3e9468c16e2875c4bf3d303749011db3810da371bfa db9a05a4-d1a3-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=198065 https://onlinelibrary.wiley.com/doi/10.1002/ijc.35200 1 0cdd2fa2-d1a3-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=198064 Medicinska fakulteta 0 0 0