Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

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

Research output: Contribution to journalJournal articleResearchpeer-review

DOI

  1. Hybrid Capture 2 and cobas human papillomavirus assays perform similarly on SurePath samples from women with abnormalities

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Clinical validation of the Cobas 4800 HPV assay using cervical samples in SurePath medium under the VALGENT4 framework

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Clinical performance of the HPV-Risk assay on cervical samples in SurePath medium using the VALGENT-4 panel

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. BAYESIAN ANALYSIS OF BASELINE RISK OF CIN2 AND ≥CIN3 BY HPV GENOTYPE IN A EUROPEAN REFERRAL COHORT

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Conization and healthcare use: a population-based register study

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

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® 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<.001, adjusted for women's age, multiple infections and the reason for taking the sample). For HC2, they were RLU/CO 11.0 (interquartile range, IQR: 3.3-52.8) vs 124.2 (IQR: 22.8-506.9), respectively; for cobas, Ct 33.5 (IQR: 29.6-37.5) vs 26.9 (IQR: 23.7-31.3), respectively; for APTIMA, S/CO 10.2 (IQR: 5.8-11.3) vs 11.1 (IQR: 9.4-15.5), respectively. Similar patterns were observed for HPV-positive ≥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
Issue number5
Pages (from-to)419-428
ISSN0956-5507
DOIs
Publication statusPublished - 1 Oct 2017

    Research areas

  • Journal Article

ID: 51682864