Clinical validation of the Cervista HPV HR test according to the international guidelines for human papillomavirus test requirements for cervical cancer screening

J Clin Microbiol. 2014 Dec;52(12):4391-3. doi: 10.1128/JCM.02716-14. Epub 2014 Oct 8.

Abstract

This study demonstrates that both the clinical sensitivity and specificity of the Cervista HPV HR test for high-risk human papillomavirus (HPV) detection are not inferior to those of the Hybrid Capture 2 (HC2) test. The intra- and interlaboratory reproducibilities of Cervista were 92.0% (kappa, 0.83) and 90.4% (kappa, 0.80), respectively. The Cervista HPV HR test fulfills all the international HPV test requirements for cervical primary screening purposes.

Publication types

  • Validation Study

MeSH terms

  • Adult
  • Female
  • Humans
  • Mass Screening / methods*
  • Middle Aged
  • Molecular Diagnostic Techniques / methods*
  • Papillomaviridae / genetics
  • Papillomaviridae / isolation & purification*
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Uterine Cervical Neoplasms / diagnosis*
  • Uterine Cervical Neoplasms / virology