Evidence map›Paper›PMID 31337408›Full record

ArticleVirology journal2019

CIN2+ detection of the HPV DNA Array genotyping assay in comparison with the Cobas 4800 HPV test and cytology.

Aleksandra Pesic, Amrei Krings, Matthias Hempel, Rosemarie Preyer, Kimon Chatzistamatiou, Theodoros Agorastos, Andreas M Kaufmann

Abstract readEvaluation Study
In one paragraph

Article in Virology journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Head-to-head comparison of the MyGene human papillomavirus-sexually transmitted infection assay versus the Cobas 4800 human papillomavirus test for detecting high-grade cervical intraepithelial neoplasia.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
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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

7 authors.

Aleksandra PesicGynaecology Clinic, Charité Universitätsmedizin, Corporate member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Hindenburgdamm 30, 12200, Berlin, Germany.
Amrei KringsGynaecology Clinic, Charité Universitätsmedizin, Corporate member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Hindenburgdamm 30, 12200, Berlin, Germany.
Matthias HempelAID/GenID Diagnostika, Ebinger Strasse 4, 72479, Strassberg, Germany.
Rosemarie PreyerAID/GenID Diagnostika, Ebinger Strasse 4, 72479, Strassberg, Germany.
Kimon Chatzistamatiou1st Department of Obstetrics and Gynecology, Papageorgiou Hospital, Aristotle University of Thessaloniki, Ring road, Nea Efkarpia, 56403, Thessaloniki, Greece.
Theodoros AgorastosIVth University Clinic of Obstetrics and Gynaecology, Hippokration General Hospital, Aristotle University, 49 Konstantinoupoleos St, 54642, Thessaloniki, Greece.
Andreas M KaufmannGynaecology Clinic, Charité Universitätsmedizin, Corporate member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Hindenburgdamm 30, 12200, Berlin, Germany. andreas.kaufmann@charite.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHPV DNA Array is an E1-targeting PCR genotyping test, with capability of distinguishing 18 high-risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) and 11 low-risk HPV types (6, 11, 40, 42, 44, 54, 67, 69, 70, 85, 97). HPV DNA Array uses multiplex PCR for E1-gene sequence amplification. The amplicons are detected and genotyped by reverse hybridization to immobilized DNA probes spotted as triplets in single 96 well-plate wells and read by AID ELISPOT reader.

methodsAim of the study was to evaluate the clinical performance of the assay against internationally accepted and FDA approved Cobas 4800 HPV test (Roche Diagnostics). Study population comprised of 500 cervical samples.

resultsHPV DNA Array demonstrated a very high sensitivity of 100% for CIN2+ and 100% for CIN3+ detection, same as Cobas 4800. HPV DNA Array showed greater sensitivity for CIN2+ detection than cytology (100% vs. 13.6%). The agreement to Cobas 4800 for HPV detection, irrespective of type, was 81.4% with κ = 0.613. The agreement for HPV 16 was 92.8% (κ = 0.929), and for HPV 18 54.2% (κ = 0.681).

conclusionHPV DNA Array demonstrated good clinical performance for detection of high-grade lesions, and may be considered for usage in a screening setting.

Indexed as

AdultAgedCervix UteriCytological TechniquesDNA, ViralEarly Detection of CancerFemaleGenotypeGenotyping TechniquesHuman papillomavirus 16Human papillomavirus 18HumansMiddle AgedOligonucleotide Array Sequence AnalysisPapillomaviridaePapillomavirus InfectionsDNA, ViralReagent Kits, DiagnosticCervical CancerHPV assayHPV detectionHuman papillomavirusValidation

Identifiers

PMID31337408
PMCPMC6651913

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Registered trials

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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.