20.500.12556/RUL-138708 Comparison of the clinical and analytical performance of Alinity m HR HPV and cobas 4800 HPV assays in a population-based screening setting Background: 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. cervical cancer human papillomavirus screening validation alinity cobas rak materničnega vratu humani papiloma virus presejanje true false true Angleški jezik Slovenski jezik Članek v reviji 2022-08-10 09:33:22 2022-08-10 09:33:25 2022-09-15 04:17:05 0000-00-00 00:00:00 2021 0 0 6 str. Vol. 140, art. 104851 Jul. 2021 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 618.1 1873-5967 10.1016/j.jcv.2021.104851 95845379 1-s2.0-S1386653221001189-main.pdf 1-s2.0-S1386653221001189-main.pdf 1 CB9387F10C8815051B44C79AFB12F311 bb29bf0559072bcb4aac6838ea365880cb5d879641f4538cb1f792e9a574d99b 6a550ab6-187f-11ed-8aca-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=159120 https://www.sciencedirect.com/science/article/pii/S1386653221001189 0 6e3aeb2e-187e-11ed-8aca-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=159119 Medicinska fakulteta 0 0 0