Clinical Validation of the cobas HPV Test on the cobas 6800 System for the Purpose of Cervical Screening

J Clin Microbiol. 2019 Jan 30;57(2):e01239-18. doi: 10.1128/JCM.01239-18. Print 2019 Feb.


This study demonstrates that the clinical sensitivity, specificity, and reproducibility of the novel cobas human papillomavirus (HPV) test on the cobas 6800 system for high-risk HPV types fulfills the criteria for use in population-based cervical screening. The criteria were formulated by an international consortium, using the cobas 4800 HPV test as a validated reference assay. The cobas HPV test detected over 98% of histologically confirmed cervical intraepithelial neoplasia grade 2+ (CIN2+) lesions in women age 30 years or older, with a specificity of 98.9% compared with the reference cobas 4800 test. Both the intra- and interlaboratory agreement for the cobas HPV test were 98%. The clinical performance of the cobas HPV test is comparable to those of longitudinally validated HPV assays and fulfills the criteria for its use in primary cervical screening.

Keywords: HPV; assay; cervical; cervical intraepithelial neoplasia; cervical screening; performance.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Early Detection of Cancer / methods*
  • Female
  • Humans
  • Longitudinal Studies
  • Middle Aged
  • Molecular Diagnostic Techniques / methods*
  • Papillomaviridae / classification*
  • Papillomaviridae / genetics
  • Papillomaviridae / isolation & purification*
  • Papillomavirus Infections / diagnosis*
  • Papillomavirus Infections / virology
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Uterine Cervical Dysplasia / diagnosis*
  • Uterine Cervical Neoplasms / diagnosis*