Comparison of the clinical and analytical performance of Alinity m HR HPV and cobas 4800 HPV assays in a population-based screening settingOštrbenk Valenčak, Anja (Avtor) Bertram, Alexander (Avtor) Gröning, Arndt (Avtor) Poljak, Mario (Avtor) cervical cancerhuman papillomavirusscreeningvalidationalinitycobasBackground: The recently launched Abbott Alinity m HR HPV (Alinity) assay separately identifies high-risk human papillomavirus (hrHPV) genotypes HPV16, HPV18, and HPV45, and reports 11 other genotypes as two aggregates. Methods: Clinical and analytical performance of Alinity was compared with the cobas 4800 HPV assay on 4,334 women aged 20–64 years attending routine, population-based organized cervical cancer screening during 2009/ 2010. After 36 months, they were invited to participate in the second screening round (2012–2014) and later followed-up through centralized national cervical cancer screening registry. Results: In women 30 and older, the clinical sensitivity for cervical intraepithelial neoplasia grade 2+ (CIN2+) was 100.0% (95% CI, 88.2–100.0%) for Alinity and 100.0% (95% CI, 88.2–100.0%) for cobas, and for CIN3+ 100.0% (95% CI, 78.9–100.0%) for both assays. The clinical specificity for ≤ CIN1 in women 30 and older was 92.4% (95% CI, 91.4–93.3%) and 92.9% (95% CI, 91.9–93.7%), respectively. The assays demonstrated excellent overall agreement for hrHPV detection (97.9%) and genotype-specific agreement for HPV16 (99.6%), HPV18 (99.8%), and other hrHPV (98.1%). Overall positive agreement and positive agreements for HPV16, HPV18, and other hrHPV genotypes were 84.3%, 89.1%, 73.2%, and 82.3%. Based on a 5-year CIN3+ risk, slightly more HPV-positive women would require referral to immediate colposcopy after testing with Alinity vs. cobas (4.1% vs. 3.8%; p = 0.470), but significantly fewer Alinity-tested women would need a 6- to 12-month follow-up visit compared with those tested with cobas (5.0% vs. 8.6%; p < 0.0001). Conclusions: Alinity and cobas have comparable clinical performance and showed excellent overall and genotypespecific agreement. The Alinity’s extended genotyping ability could help predict the 5-year CIN3+ risk and costsaving management of HPV-screen-positive women.20212022-08-10 09:33:22Članek v reviji138708UDK: 618.1ISSN pri članku: 1873-5967DOI: 10.1016/j.jcv.2021.104851COBISS_ID: 95845379sl