Evidence map›Paper›PMID 26019212›Full record

ArticleJournal of clinical microbiology2015

Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany.

Thomas Iftner, Sven Becker, Klaus-Joachim Neis, Alejandra Castanon, Angelika Iftner, Barbara Holz, Annette Staebler, Melanie Henes, Katharina Rall, Juliane Haedicke and 4 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyEvaluation Study
In one paragraph

Article in Journal of clinical microbiology, 2015. 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 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 pooled it
6.5field-weighted citation impact, top 3% of its field
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

40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 97 citations in OpenAlex.

  1. Pooled it
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  7. Evolving HPV diagnostics: current practice and future frontiers.Frontiers in cellular and infection microbiology · 2025
    Review
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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

14 authors at 3 institutions in 2 countries.

Thomas IftnerDivision of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Tübingen, Germany thomas.iftner@med.uni-tuebingen.de.
Sven BeckerDepartment of Gynecology and Obstetrics, University Hospital Tübingen, Tübingen, Germany.
Klaus-Joachim NeisFrauenärzte am Staden, Saarbrücken, Germany.
Alejandra CastanonCentre for Cancer Prevention, Queen Mary University of London, London, United Kingdom.
Angelika IftnerDivision of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Tübingen, Germany.
Barbara HolzDivision of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Tübingen, Germany.
Annette StaeblerDepartment of Pathology and Neuropathology, University Hospital Tübingen, Tübingen, Germany.
Melanie HenesDepartment of Gynecology and Obstetrics, University Hospital Tübingen, Tübingen, Germany.
Katharina RallDepartment of Gynecology and Obstetrics, University Hospital Tübingen, Tübingen, Germany.
Juliane HaedickeDivision of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Tübingen, Germany.
Claus Hann von WeyhernDepartment of Pathology and Neuropathology, University Hospital Tübingen, Tübingen, Germany.
Andreas CladDepartment of Gynecology, Obstetrics, and Medical Microbiology, Albert Ludwigs University of Freiburg, Freiburg, Germany.
Sara BruckerDepartment of Gynecology and Obstetrics, University Hospital Tübingen, Tübingen, Germany.
Peter SasieniCentre for Cancer Prevention, Queen Mary University of London, London, United Kingdom.
University Children's Hospital Tübingen · DEQueen Mary University of London · GBUniversity of Freiburg · DE

Funding

Cancer Research UK 16892Cancer Research UK 16893
6 · The paper itself

Abstract

Testing for E6/E7 mRNA in cells infected with high-risk (HR) human papillomavirus (HPV) might improve the specificity of HPV testing for the identification of cervical precancerous lesions. Here we compared the RNA-based Aptima HPV (AHPV) assay (Hologic) and the DNA-based Hybrid Capture 2 (HC2) HPV test (Qiagen) to liquid-based cytology (LBC) for women undergoing routine cervical screening. A total of 10,040 women, 30 to 60 years of age, were invited to participate in the study, 9,451 of whom were included in the analysis. Specimens were tested centrally by LBC, the AHPV test, and the HC2 test, and women who tested positive on any test were referred for colposcopy. Genotyping was performed on all HR-HPV-positive samples. Test characteristics were calculated based on histological review. As a result, we identified 90 women with cervical intraepithelial neoplasia grade 2+ (CIN2+), including 43 women with CIN3+. Sensitivity differences between the AHPV test and the HC2 test in detecting CIN2+ (P = 0.180) or CIN3+ (P = 0.0625) lesions were statistically nonsignificant. Of three CIN3 cases that were missed with the AHPV test, two cases presented lesion-free cones and one had a non-HR HPV67 infection. The specificity (<CIN2) and positive predictive value (CIN2+) of the AHPV test were significantly higher (both P < 0.001) than those of the HC2 test. The overall agreement between the tests was substantial (κ = 0.77). Finally, we present results for several possible triage strategies, based on the primary screening test being either the AHPV test or the HC2 test. In summary, the AHPV assay is both specific and sensitive for the detection of high-grade precancerous lesions and may be used in primary cervical cancer screening for women ≥30 years of age.

Indexed as

AdultCytological TechniquesDNA, ViralEarly Detection of CancerFemaleGenotypeGermanyHistocytochemistryHumansMiddle AgedMolecular Diagnostic TechniquesPapillomaviridaePapillomavirus InfectionsPrecancerous ConditionsPredictive Value of TestsRNA, MessengerDNA, ViralRNA, MessengerRNA, Viral

Identifiers

PMID26019212
PMCPMC4508437
OpenAlexW1729453366

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.