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

Kwaliteit van de gezondheidszorg  
Ziekten en gezondheid in kaart brengen  
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Public Access

Published

Peer reviewed scientific article

Engels

DOI : https://doi.org/10.3390/ijms19092704 [2]

Auteurs

Lan Xu [3]; Padalko, Elizaveta [4]; M. Arbyn [5]

Trefwoorden

  1. Alphapapillomavirus [6]
  2. Cervical Intraepithelial Neoplasia [7]
  3. Cervix Uteri [8]
  4. Diagnostic Tests, Routine [9]
  5. DNA, Viral [10]
  6. Early Detection of Cancer [11]
  7. Female [12]
  8. Genotyping Techniques [13]
  9. Humans [14]
  10. Papillomavirus Infections [15]
  11. Uterine Cervical Neoplasms [16]
Article written during project(s) : 
VALGENT Klinische validatie van tests op het humaan papillomavirus (VALGENT) [17]

Samenvatting:

In this diagnostic test validation study, we assessed the clinical accuracy and HPV genotyping performance of the INNO-LiPA HPV Genotyping 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 asse…
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Samenvatting

In this diagnostic test validation study, we assessed the clinical accuracy and HPV genotyping performance of the INNO-LiPA HPV Genotyping 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; = 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; = 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.

Associated health topics:

Kwaliteit van de gezondheidszorg [18]
Kanker [19]

Source URL:https://www.sciensano.be/nl/biblio/clinical-evaluation-inno-lipa-hpv-genotyping-ii-assay-using-valgent-framework

Links
[1] https://www.sciensano.be/sites/default/files/xuarbyn2018intjmolsci.pdf [2] https://doi.org/10.3390/ijms19092704 [3] https://www.sciensano.be/nl/biblio?f%5Bauthor%5D=87232&f%5Bsearch%5D=Lan%20Xu [4] https://www.sciensano.be/nl/biblio?f%5Bauthor%5D=35769&f%5Bsearch%5D=Padalko%2C%20Elizaveta [5] https://www.sciensano.be/nl/people/marc-arbyn/biblio [6] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=33603&f%5Bsearch%5D=Alphapapillomavirus [7] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=3231&f%5Bsearch%5D=Cervical%20Intraepithelial%20Neoplasia [8] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=33597&f%5Bsearch%5D=Cervix%20Uteri [9] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=31482&f%5Bsearch%5D=Diagnostic%20Tests%2C%20Routine [10] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=29022&f%5Bsearch%5D=DNA%2C%20Viral [11] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=33630&f%5Bsearch%5D=Early%20Detection%20of%20Cancer [12] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=2685&f%5Bsearch%5D=Female [13] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=17814&f%5Bsearch%5D=Genotyping%20Techniques [14] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=648&f%5Bsearch%5D=Humans [15] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=33132&f%5Bsearch%5D=Papillomavirus%20Infections [16] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=32811&f%5Bsearch%5D=Uterine%20Cervical%20Neoplasms [17] https://www.sciensano.be/nl/projecten/klinische-validatie-van-tests-op-het-humaan-papillomavirus-valgent [18] https://www.sciensano.be/nl/gezondheidsonderwerpen/kwaliteit-van-de-gezondheidszorg [19] https://www.sciensano.be/nl/gezondheidsonderwerpen/kanker