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

The challenges of defining sample adequacy in an era of HPV based cervical screening

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Aseptic meningitis outbreak associated with echovirus 4 in Northern Europe in 2013-2014

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. 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

  3. 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

  4. Taking gastro-surveillance into the 21st century

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Human Papillomavirus Same Genotype Persistence and Risk: A Systematic Review

    Research output: Contribution to journalReviewpeer-review

  2. FAM19A4/miR124-2 methylation in invasive cervical cancer: A retrospective cross-sectional worldwide study

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. 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

View graph of relations

BACKGROUND: The implementation of Human Papillomavirus based cervical screening continues apace on a global scale. Understanding the basis and burden of inadequate or invalid samples is important to ensure confidence in high quality laboratory results and inform the development of new technologies. Here we present population based data from Scotland and Denmark which detail the extent of invalid samples for HPV detection in both clinician-taken and self-taken samples. As a comparator we report on the rate of inadequate cytology preparations in both countries.

METHODS: The proportion of samples with an invalid HPV test result was calculated by retrospective analysis of routine laboratory data associated with cervical screening programmes in the two countries. Two assays were in use for the programmes at the time (the Abbott RealTime High Risk HPV assay and the BD Onclarity); both have internal endogenous controls for human genes. In addition, acellular cytology samples were reported through a prospective audit (Scotland) and National quality reporting (Denmark).

RESULTS: In total, 89,418 clinician samples and 14,677 self-taken samples were assessed. We observed low rates of invalid HPV tests in clinician taken samples (0.05-0.10 %), irrespective of sample collection media (ThinPrep or SurePath), HPV test system/endogenous control type or clinical indication for testing (primary screening, triage or test of cure). For self-taken samples, the number of invalid samples was 0.18 %. Complete absence of sample material (acellular) in clinician taken samples were observed at a level of 1 in approximately 16.5 thousand.

CONCLUSIONS: Clinician and self-taken samples appear robust specimens for HPV testing and acellular samples are very rare. Efforts to develop endogenous controls for HPV assays that provide greater insight into true sample adequacy for cervical disease detection, beyond measuring the presence of human cells, will be welcome.

Original languageEnglish
Article number104756
JournalJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology
Volume137
Pages (from-to)1-4
Number of pages4
ISSN1386-6532
DOIs
Publication statusPublished - 1 Apr 2021

Bibliographical note

Publisher Copyright:
© 2021

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

    Research areas

  • Cellular invalidity, HPV primary screening

ID: 64082265