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Sisse Helle Njor

Referral population studies underestimate differences between human papillomavirus assays in primary cervical screening

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DOI

  • M. Rebolj, Copenhagen Univ Hosp, University of Copenhagen, Rigshosp, Dept Pathol
  • ,
  • S. Njor
  • E. Lynge, Univ Copenhagen, University of Copenhagen, Dept Publ Hlth, Biostat Sect
  • ,
  • S. Preisler, Copenhagen Univ Hosp, University of Copenhagen, Rigshosp, Dept Pathol
  • ,
  • D. Ejegod, Copenhagen Univ Hosp, University of Copenhagen, Rigshosp, Dept Pathol
  • ,
  • C. Rygaard, Copenhagen Univ Hosp, University of Copenhagen, Rigshosp, Dept Pathol
  • ,
  • J. Bonde, Copenhagen Univ Hosp, University of Copenhagen, Copenhagen Trial Unit, Ctr Clin Intervent Res, Rigshosp, Copenhagen Univ Hosp, University of Copenhagen, Rigshosp, Dept Pathol

Objective: We studied how representative cytologically abnormal women ("referral populations") are with respect to uncovering differences between human papillomavirus (HPV) assays in the primary screening where most women are cytologically normal.

Methods: A total of 4997 women were tested with SurePath (R) cytology, and Hybrid Capture 2 (HC2), cobas, CLART and APTIMA HPV assays. Women with positive test results were offered a follow-up. For all detected HPV infections and HPV-positive high-grade cervical intraepithelial neoplasia (>= CIN2), we studied the distributions of assay-specific signal strengths in the baseline samples as documented by the assays' automatically generated reports. We calculated the likelihood of test result discordance as the proportion of HPV-positive samples that were not confirmed by all four assays.

Results: Median signal strengths for HPV infections were weaker in normal than abnormal cytology (P= CIN2. The four HPV assays more frequently returned discordant test results in normal than in abnormal cytology. Relative frequency of discordance in detecting HPV infections was 0.39 (95% confidence interval: 0.33-0.48) for abnormal vs normal cytology.

Conclusions: These data suggest that referral population studies, by not including sufficient numbers of cytology normal women, underestimate the differences between HPV assays that would become apparent in primary screening.

Original languageEnglish
JournalCytopathology
Volume28
Issue5
Pages (from-to)419-428
Number of pages10
ISSN0956-5507
DOIs
Publication statusPublished - Oct 2017

    Research areas

  • assays, cervical cancer, cytology, human papillomavirus, mass screening, HYBRID CAPTURE 2, MESSENGER-RNA ASSAY, RANDOMIZED CONTROLLED-TRIALS, COBAS 4800 HPV, INTRAEPITHELIAL NEOPLASIA, CLINICAL-PERFORMANCE, TEST REQUIREMENTS, SUREPATH SAMPLES, FOLLOW-UP, WOMEN

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