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Region Hovedstaden - en del af Københavns Universitetshospital
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The Valgent4 protocol: Robust analytical and clinical validation of 11 HPV assays with genotyping on cervical samples collected in SurePath medium

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. Clinical performance of the HPV-Risk assay on cervical samples in SurePath medium using the VALGENT-4 panel

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  1. Clinical Utility of Human Papillomavirus Genotyping in Cervical Cancer Screening: A Systematic Review

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  2. Clinical performance of the HPV-Risk assay on cervical samples in SurePath medium using the VALGENT-4 panel

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. BAYESIAN ANALYSIS OF BASELINE RISK OF CIN2 AND ≥CIN3 BY HPV GENOTYPE IN A EUROPEAN REFERRAL COHORT

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  • Jesper Bonde
  • Ditte Møller Ejegod
  • Kate Cuschieri
  • Joakim Dillner
  • Daniëlle A M Heideman
  • Wim Quint
  • Miguel Angel Pavon Ribas
  • Elizaveta Padalko
  • Irene Kraus Christiansen
  • Lan Xu
  • Marc Arbyn
Vis graf over relationer

BACKGROUND: The VALidation of HPV GENoyping Tests (VALGENT) is an international initiative designed to validate HPV assays with genotyping capability. The VALGENT4 protocol differs from previous VALGENT installments as the sample collection medium is SurePath, and exclusively includes samples from women ≥30 years of age which is concordant with the majority of HPV primary screening guidelines. Here we present the protocol for the fourth installment of the VALGENT framework.

OBJECTIVES: In VALGENT4 11 HPV assays will be evaluated using two comparator assays based on PCR with the GP5+/6+ primers.

STUDY DESIGN: Overall, the VALGENT4 panel consists of 1,297 routine samples comprised of 998 unselected, consecutive samples, of which 51 samples had abnormal cytology with 13 women diagnosed with ≥CIN2, and 299 consecutive samples enriched for ≥ASCUS cytology (100 ASCUS, 100 LSIL, 99 HSIL) with 106 ≥CIN2 upon follow up. Manipulated and DNA extracted panel samples were characterized with respect to human beta globin (HBB) and overall DNA content and composition to quality assess the panel prior to distribution to the collaborating sites.

RESULT: The relative cellularity (mean CT value of HBB from the Onclarity assay) on the 1,297 LBC samples (CT=24.8) was compared with 293 un-manipulated routine cytology screening samples (CT=23.8). Furthermore, the DNA extracted panel samples was characterized using the Exome iPLEX pro assay, which reports amplifiable copies on individual samples as well as copies of five different base pair lengths. Here the data showed a slightly lower number of amplifiable DNA copies (ratio: 0.7, p=<0.01)) in the VALGENT4 panel samples compared to routine extracted cervical DNA samples CONCLUSION: The present manuscript details the manipulation, processing and quality assessment of samples used in VALGENT-4. This methodological document may be of value for future international projects of HPV test validation.

OriginalsprogEngelsk
TidsskriftJournal of Clinical Virology
Vol/bind108
Sider (fra-til)64-71
Antal sider8
ISSN1386-6532
DOI
StatusUdgivet - 1 nov. 2018

ID: 55339733