Quality assurance of human papillomavirus (HPV) testing in the implementation of HPV primary screening in Norway: An inter-laboratory reproducibility study

Birgit Engesæter, Bianca van Diermen Hidle, Mona Hansen, Pia Moltu, Kjersti Mangseth Staby, Siri Borchgrevink-Persen, Olav K. Vintermyr, Stefan Lönnberg, Mari Nygård, Emiel A.M. Janssen, Philip E. Castle, Irene Kraus Christiansen

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

Background: Human papillomavirus (HPV) testing as primary screening for cervical cancer is currently being implemented in Norway in a randomized controlled fashion, involving three laboratories. As part of the quality assurance programme of the implementation, an evaluation of the inter-laboratory reproducibility of the HPV test was initiated, to ensure satisfactory HPV test reliability in all three laboratories. Methods: The HPV test used is the cobas 4800 HPV Test, detecting 14 high-risk types with individual HPV genotype results for HPV16 and HPV18. In addition to the three laboratories involved in the implementation, the Norwegian HPV reference laboratory was included as a fourth comparative laboratory. A stratified sample of 500 cervical liquid based cytology (LBC) samples was used in the evaluation, with an aim towards a high-risk HPV positivity of ~25%. Samples were collected at one laboratory, anonymized, aliquoted, and distributed to the other laboratories. Results: Comparison of the test results of all four laboratories revealed a 95.6% agreement, an 86.3% positive agreement and a kappa value of 0.94 (95% CI 0.92-0.97). For negative cytology specimens, there was a 95.8% overall agreement, a 67.4% positive agreement, and a kappa value of 0.88 (95% CI 0.80-0.93). For abnormal cytology specimens, there was a 95.8% overall agreement, a 95.5% positive agreement, and a kappa value of 0.86 (95% CI 0.71-0.97). Conclusions: The study showed a high inter-laboratory reproducibility of HPV testing, implying satisfactory user performance and reliability in the laboratories involved in the implementation project. This is important knowledge and we recommend similar studies always to be performed prior to the introduction of new screening routines.

Original languageEnglish (US)
Article number698
JournalBMC Infectious Diseases
Volume16
Issue number1
DOIs
StatePublished - Nov 24 2016

Keywords

  • Cervical cancer screening
  • Cobas 4800 HPV Test
  • HPV
  • HPV primary screening
  • HPV testing
  • Human papillomavirus
  • Inter-laboratory reproducibility
  • Quality assurance

ASJC Scopus subject areas

  • Infectious Diseases

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    Engesæter, B., van Diermen Hidle, B., Hansen, M., Moltu, P., Staby, K. M., Borchgrevink-Persen, S., Vintermyr, O. K., Lönnberg, S., Nygård, M., Janssen, E. A. M., Castle, P. E., & Christiansen, I. K. (2016). Quality assurance of human papillomavirus (HPV) testing in the implementation of HPV primary screening in Norway: An inter-laboratory reproducibility study. BMC Infectious Diseases, 16(1), [698]. https://doi.org/10.1186/s12879-016-2028-7