Evidence map›Paper›PMID 30355760›Full record

ArticleJournal of clinical microbiology2019

Longitudinal Clinical Performance of the RNA-Based Aptima Human Papillomavirus (AHPV) Assay in Comparison to the DNA-Based Hybrid Capture 2 HPV Test in Two Consecutive Screening Rounds with a 6-Year Interval in Germany.

Thomas Iftner, Klaus-Joachim Neis, Alejandra Castanon, Rebecca Landy, Barbara Holz, Astrid Woll-Herrmann, Angelika Iftner, Annette Staebler, Diethelm Wallwiener, Claus Hann von Weyhern and 6 more

Registry-linked trialAbstract readComparative StudyEvaluation Study
In one paragraph

Article in Journal of clinical microbiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02634190 (Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HPV HC2® Test in Women 30 Years of Age or Older Using LBC ThinPrep® Pap Test Specimens), which is not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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.

NCT02634190 completednot on this map

Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HPV HC2® Test in Women 30 Years of Age or Older Using LBC ThinPrep® Pap Test Specimens

TypeobservationalSponsorHologic Deutschland GmbHRan2009 to 2021Enrolled10,000ConditionsHuman Papilloma Virus InfectionArmsThinprep® LBC, APTIMA® HPV Assay, HR HC2® HPV DNA, Colposcopy
3 · Its place in the literature

Who cites it

25 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. A review of urinary HPV testing for cervical cancer management and HPV vaccine surveillance: rationale, strategies, and limitations.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2024
    Review
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Observational
  14. Article
  15. Article
  16. Article
  17. Article
  18. The IARC Perspective on Cervical Cancer Screening.The New England journal of medicine · 2021
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Thomas IftnerInstitute of Medical Virology and Epidemiology of Viral Diseases, University Hospital Tübingen, Tübingen, Germany thomas.iftner@med.uni-tuebingen.de peter.sasieni@kcl.ac.uk.
Klaus-Joachim NeisFrauenärzte am Staden, Saarbrücken, Germany.
Alejandra CastanonCentre for Cancer Prevention, Queen Mary University of London, London, United Kingdom.
Rebecca LandyCentre for Cancer Prevention, Queen Mary University of London, London, United Kingdom.
Barbara HolzInstitute of Medical Virology and Epidemiology of Viral Diseases, University Hospital Tübingen, Tübingen, Germany.
Astrid Woll-HerrmannFrauenärzte am Staden, Saarbrücken, Germany.
Angelika IftnerInstitute of Medical Virology and Epidemiology of Viral Diseases, University Hospital Tübingen, Tübingen, Germany.
Annette StaeblerDepartment of Pathology and Neuropathology, University Hospital Tübingen, Tübingen, Germany.
Diethelm WallwienerDepartment of Gynaecology and Obstetrics, University Hospital Tübingen, Tübingen, Germany.
Claus Hann von WeyhernDepartment of Pathology and Neuropathology, University Hospital Tübingen, Tübingen, Germany.
Felix NeisDepartment of Gynaecology and Obstetrics, University Hospital Tübingen, Tübingen, Germany.
Juliane Haedicke-JarbouiInstitute of Medical Virology and Epidemiology of Viral Diseases, University Hospital Tübingen, Tübingen, Germany.
Peter MartusMedical Faculty Tübingen, Institute for Clinical Epidemiology and Applied Biometry, Tübingen, Germany.
Sara BruckerDepartment of Gynaecology and Obstetrics, University Hospital Tübingen, Tübingen, Germany.
Melanie HenesDepartment of Gynaecology and Obstetrics, University Hospital Tübingen, Tübingen, Germany.
Peter SasieniCentre for Cancer Prevention, Queen Mary University of London, London, United Kingdom thomas.iftner@med.uni-tuebingen.de peter.sasieni@kcl.ac.uk.

Funding

Cancer Research UK 16892Cancer Research UK 27047Cancer Research UK A16892
6 · The paper itself

Abstract

Longitudinal data on the E6/E7 mRNA-based Aptima human papillomavirus (AHPV) assay exceeding three years in comparison to the gold standard Digene Hybrid Capture 2 (HC2) test are not available. We previously reported the cross-sectional data of the German AHPV Screening Trial (GAST) in which 10,040 women were recruited and tested by liquid-based cytology, the HC2 assay, and the AHPV assay. Four hundred eleven test-positive women were followed for up to six years. In addition, 3,295 triple-negative women were screened after a median time of six years. Overall, 28 high-grade cervical intraepithelial neoplasia (CIN3) cases were detected. The absolute risk of developing high-risk HPV-positive CIN3+ over six years among those women that tested negative at baseline was 2.2 (95% confidence interval [95% CI], 1.0 to 4.9) and 3.1 (95% CI, 1.7 to 5.7) per 1,000 women screened by the HC2 and the AHPV tests; the additional risk for those with AHPV-negative compared with HC2-negative results was 0.9 (95% CI, -0.2 to 2.1) per 1,000. In comparison, the absolute risk following a negative LBC test was 9.3 (95% CI, 2.9 to 30.2). The relative sensitivity of AHPV compared to HC2 was 91.5% for CIN3+, and the negative predictive values were 99.8% (95% CI, 99.5 to 99.9%) for HC2 and 99.7% (95% CI, 99.4 to 99.8%) for AHPV. Our data show that the longitudinal performance of the AHPV test over six years is comparable to the performance of the HC2 test and that the absolute risk of CIN3+ over six years following a negative AHPV result in a screening population is low. (This study is registered at ClinicalTrials.gov under registration number NCT02634190.).

Indexed as

AdultDNA, ViralEarly Detection of CancerFemaleGermanyHumansLongitudinal StudiesMiddle AgedMolecular Diagnostic TechniquesOncogene Proteins, ViralPapillomaviridaePapillomavirus InfectionsRNA, MessengerRNA, ViralSensitivity and SpecificityUterine Cervical DysplasiaDNA, ViralOncogene Proteins, ViralRNA, MessengerRNA, ViralAptima HPVcervical cancer screeningcervical intraepithelial neoplasiaE6/E7 mRNA

Identifiers

PMID30355760
PMCPMC6322477

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.