ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2024
Human papillomavirus negative high grade cervical lesions and cancers: Suggested guidance for HPV testing quality assurance.
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
8 citing papers in PubMed, 7 citations in OpenAlex.
- Epidemiological Profile of High-Risk HPV in Cervical Samples for Liquid-Based Cytology: Insights from Screening and Symptomatic Cohorts.Microorganisms · 2026Article
- Causative Human Papillomavirus (HPV) Genotypes of Anal Cancers in Australian Cisgender Women.Journal of medical virology · 2026Article
- Negative Xpert HPV Test (Cepheid) With Late Amplification Signals: Is There a Clinical Significance? (the PaPCR Study).Journal of medical virology · 2026Article
- Cervical Cancer Screening: Histologic Outcomes of HPV-Negative HSIL/ASC-H Cytology in a Tertiary Referral Cohort in Northern Thailand.Medicina (Kaunas, Lithuania) · 2026Article
- Immunosuppression as an associated risk factor for high-grade cervical lesions: a comparative study of cytology, HPV, and histopathology.Frontiers in surgery · 2026Article
- Human Papillomavirus Primary Screening and Collaboration in Quality Assurance Work between Laboratories.Acta cytologica · 2026Review
- Comparative Oncologic Outcomes in High-Risk Human Papillomavirus-Positive and -Negative Cervical Intraepithelial Neoplasia.Medical science monitor : international medical journal of experimental and clinical research · 2025Article
- Quality Assurance in Cervical Cancer Screening: Evaluation of Sample Adequacy in HPV DNA Testing.Journal of medical virology · 2025Article
Corrections and comments
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Authors and funding
28 authors at 11 institutions in 10 countries.
Funding
Abstract
backgroundSome 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).
methodsThere 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.
resultStandard 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.
conclusionMonitoring the proportion of and reasons for failure to detect HPV in HSIL+ will help support high performance and quality improvement of HPV testing services. We encourage implementation of QA strategies based on re-analysis of "HPV negative" HSIL+ samples.
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Registered trials
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