Clinical and analytical performance of the PapilloCheck HPV-Screening assay using the VALGENT framework

J Clin Virol. 2016 Aug;81:6-11. doi: 10.1016/j.jcv.2016.05.004. Epub 2016 May 19.

Abstract

Background: The benefit of HPV testing for cervical cancer screening and disease management has been shown in many recent studies and is part of several new evidence-based guidelines. Assessment of emerging HPV tests in this context is essential, using well-annotated samples, such as those generated via the Validation of Genotyping Tests-HPV (VALGENT) framework.

Objective: Our aim was to assess the PapilloCheck HPV assay in terms of absolute and relative accuracy for primary cervical cancer screening, using a standard comparator test (GP5+/6+EIA)already validated in randomised trials.

Study design: Type-specific HPV prevalence was stratified by age and cytology grade and compared with the luminex typing assay incorporating a GP5+6+ PCR (GP5+/6+ LMNX Assay). Clinical outcomes were compared with GP5+/6+EIA.

Results: Prevalence of hrHPV types (high-risk HPV) increased with severity of cytology. The concordance between PapilloCheck and the GP5+/6+ LMNX Assay was excellent when assessed at the qualitative hrHPV presence/absence level also at the type-specific level in the whole population and in women over 30 years of age. Absolute clinical sensitivity and specificity of the PapilloCheck was high and ranged between 95.5% and 98.2% for sensitivity and between 82.7% and 91.6% for specificity, depending on the outcome and population.

Conclusion: The sensitivity and specificity of this assay for the outcomes of CIN2+ were similar to those of the standard comparator assay, GP5+/6+ EIA.

Keywords: Cervical cancer screening; Diagnostic test accuracy; Human papillomavirus; Validation of tests.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Cross-Sectional Studies
  • Early Detection of Cancer
  • Female
  • Genotyping Techniques / methods*
  • Humans
  • Middle Aged
  • Molecular Diagnostic Techniques
  • Papanicolaou Test
  • Papillomaviridae / genetics*
  • Papillomavirus Infections / diagnosis*
  • Papillomavirus Infections / epidemiology
  • Papillomavirus Infections / virology*
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Uterine Cervical Neoplasms / diagnosis
  • Uterine Cervical Neoplasms / virology
  • Young Adult