20.500.12556/RUL-131628 Clinical evaluation of INNO-LiPA HPV Genotyping EXTRA II assay using the VALGENT framework In this diagnostic test validation study, we assessed the clinical accuracy and HPV genotyping performance of the INNO-LiPA HPV Genotyping Extra II (INNO-LiPA) within the VALGENT-3 framework. VALGENT is designed to assess the analytical and clinical performance of HPV tests with genotyping capacity. The VALGENT-3 panel comprised 1300 consecutive cervical cell specimens enriched with 300 samples with abnormal cytology obtained from women attending the Slovenian cervical cancer screening programme. The INNO-LiPA allows type-specific detection of 32 HPV types; however, for the clinical accuracy assessment, we considered it as high-risk (hr)HPV positive when at least one of the following HPV types was present: HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, and HPV68. Clinical accuracy for detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) was compared between INNO-LiPA and Hybrid Capture 2 (HC2), which is a standard comparator test for HPV tests used in cervical cancer screening. In addition, hrHPV and type-specific detection HPV types were compared between INNO-LiPA and Linear Array HPV Genotyping Test (Linear Array). The prevalence of hrHPV determined by INNO-LiPA was 17.1% (95% CI, 15.0–19.2%) in the screening population. HrHPV testing with INNO-LiPA had a sensitivity for CIN2+ of 96.9% (95% CI, 92.1–99.1%) which was non-inferior to HC2 (relative sensitivity of 1.01; 95% CI, 0.97–1.04; p$_{n.inf}$ = 0.0002) and a specificity for ≤CIN1 of 85.3% (95% CI, 83.2–87.3%) which was inferior to HC2 (relative specificity of 0.95; 95% CI, 0.93–0.97; p$_{n.inf}$ = 0.9998). Genotyping agreement between INNO-LiPA and Linear Array was excellent for hrHPV, HPV16, HPV18, HPV35, HPV45, HPV58 and HPV59, but good or fair for other HPV types. To conclude, INNO-LiPA demonstrated non-inferior clinical sensitivity but lower specificity compared to HC2 in addition to excellent concordance compared to Linear Array for hrHPV and some genotypes. INNO-LiPA VALGENT HPV genotyping cervical cancer human papillomavirus clinical validation Hybrid Capture 2 Linear Array HPV INNO - LiPA HPV genotyping EXTRA II humani papiloma virus HPV genotipizacija rak materničnega vratu true false true Angleški jezik Slovenski jezik Članek v reviji 2021-09-30 11:48:48 2021-09-30 12:09:06 2023-01-27 09:05:42 0000-00-00 00:00:00 2018 0 0 11 str. iss. 9, art. 2704 Vol. 19 Sep. 2018 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 1422-0067 10.3390/ijms19092704 129639683 RAZ_Xu_Lan_2018.pdf RAZ_Xu_Lan_2018.pdf 1 EF91254A13739BD8F09FAACBB73D7247 fc610d2e461cdf2573eaef1aab5ec5b31707bac890864c51243929ef5c620d72 ff3a9945-21dc-11ec-a523-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=149010 https://www.mdpi.com/1422-0067/19/9/2704 0 f11eb6ea-21d5-11ec-a523-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=149004 Medicinska fakulteta 0 0 0