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Clinical evaluation of INNO-LiPA HPV Genotyping EXTRA II assay using the VALGENT framework
Xu, Lan (Avtor), Padalko, Elizaveta (Avtor), Oštrbenk, Anja (Avtor), Poljak, Mario (Avtor), Arbyn, Marc (Avtor)

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Izvleček
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.

Jezik:Angleški jezik
Ključne besede:INNO-LiPA, VALGENT, HPV genotyping, cervical cancer, human papillomavirus, clinical validation, Hybrid Capture 2, Linear Array, HPV, INNO - LiPA HPV genotyping EXTRA II
Vrsta gradiva:Članek v reviji (dk_c)
Organizacija:MF - Medicinska fakulteta
Leto izida:2018
Št. strani:11 str.
Številčenje:Vol. 19, iss. 9, art. 2704
ISSN pri članku:1422-0067
DOI:10.3390/ijms19092704 Povezava se odpre v novem oknu
Število ogledov:86
Število prenosov:30
Metapodatki:XML RDF-CHPDL DC-XML DC-RDF
 
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Gradivo je del revije

Naslov:International journal of molecular sciences
Skrajšan naslov:Int. j. mol. sci.
Založnik:MDPI
ISSN:1422-0067
COBISS.SI-ID:2779162 Povezava se odpre v novem oknu

Gradivo je financirano iz projekta

Financer:EC - European Commission
Program financ.:FP7
Številka projekta:603019
Naslov:Comparing health services interventions for the prevention of HPV-related cancer
Akronim:COHEAHR

Licence

Licenca:CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
Povezava:http://creativecommons.org/licenses/by/4.0/deed.sl
Opis:To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.
Začetek licenciranja:11.09.2018

Sekundarni jezik

Jezik:Slovenski jezik
Ključne besede:HPV, INNO - LiPA HPV genotip EXTRA II, VALGENT

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