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Int. J. Mol. Sci. 2018, 19(9), 2704; https://doi.org/10.3390/ijms19092704

Clinical Evaluation of INNO-LiPA HPV Genotyping EXTRA II Assay Using the VALGENT Framework

1
Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano (Previously Scientific Institute of Public Health), 1050 Brussels, Belgium
2
Department of Clinical Chemistry, Microbiology and Immunology, Ghent University Hospital, 9000 Gent, Belgium
3
Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, Slovenia
These authors contributed equally to this work.
*
Author to whom correspondence should be addressed.
Received: 12 August 2018 / Revised: 5 September 2018 / Accepted: 6 September 2018 / Published: 11 September 2018
(This article belongs to the Special Issue Molecular Research on Cervical Cancer)
Full-Text   |   PDF [239 KB, uploaded 11 September 2018]

Abstract

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; pn.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; pn.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. View Full-Text
Keywords: INNO-LiPA; VALGENT; HPV genotyping; cervical cancer; human papillomavirus; clinical validation; Hybrid Capture 2; Linear Array INNO-LiPA; VALGENT; HPV genotyping; cervical cancer; human papillomavirus; clinical validation; Hybrid Capture 2; Linear Array
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).
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Xu, L.; Padalko, E.; Oštrbenk, A.; Poljak, M.; Arbyn, M. Clinical Evaluation of INNO-LiPA HPV Genotyping EXTRA II Assay Using the VALGENT Framework. Int. J. Mol. Sci. 2018, 19, 2704.

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