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Human Papillomavirus Negative High Grade Cervical Lesions and Cancers: Suggested Guidance for Hpv Testing Quality Assurance

SSRN, ISSN: 1556-5068
2023
  • 0
    Citations
  • 328
    Usage
  • 0
    Captures
  • 0
    Mentions
  • 0
    Social Media
Metric Options:   Counts1 Year3 Year

Metrics Details

  • Usage
    328
    • Abstract Views
      246
    • Downloads
      82
  • Ratings
    • Download Rank
      612,708

Article Description

Background: Some high-grade cervical lesions and cervical cancers (HSIL+) test negative for human papillomavirus (HPV). The HPV-negative fraction varies between 0.03% and 15% between different laboratories. Monitoring and extended re-analysis of HPV-negative HSIL+ could thus be helpful to monitor performance of HPV testing services. We aimed to a) provide a real-life example of a quality assurance (QA) program based on re-analysis of HPV-negative HSIL+ and b) develop international guidance for QA of HPV testing services based on standardized identification of apparently HPV-negative HSIL+ and extended re-analysis, either by the primary laboratory or by a national HPV reference laboratory (NRL). Methods: There were 116 initially HPV-negative cervical specimens (31 histopathology specimens and 85 liquid-based cytology samples) sent to the Swedish HPV Reference Laboratory for re-testing. Based on the results, an international QA guidance was developed through an iterative consensus process. Result: Standard PCR testing detected HPV in 55.2% (64/116) of initially “HPV-negative” samples. Whole genome sequencing of PCR-negative samples identified HPV in an additional 7 samples (overall 61.2% HPV positivity). Reasons for failure to detect HPV in an HSIL+ lesion are listed and guidance to identify cases for extended re-testing, including which information should be included when referring samples to an NRL are presented. Conclusion: Monitoring the proportion of and reasons for failure to detect HPV in HSIL+ will be helpful to promote high performance of HPV testing services. We encourage implementation of QA strategies based on re-analysis of “HPV negative” HSIL+ samples.

Bibliographic Details

Jean Luc Pretét; Laila Sara Arroyo Mühr; Kate Cuschieri; María Dolores Fellner; Rita Mariel Correa; María Alejandra Picconi; Suzanne Marie Garland; Gerald L. Murray; Mónica Molano; Michael Peeters; Steven Van Gucht; Charlotte Lambrecht; Davy Vanden Broeck; Elizaveta Padalko; Marc Arbyn; Quentin Lepiller; Alice Brunier; Steffi Silling; Kristiane Søreng; Irene Kraus Christiansen; Mario Poljak; Camilla Lagheden; Emel Yilmaz; Carina Eklund; Hem R. Thapa; Troy D. Querec; Elizabeth R. Unger; Joakim Dillner

Elsevier BV

Multidisciplinary; human papillomavirus; HSIL; Cervical Cancer; quality assurance; HPV testing; screening

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