Evidence map›Paper›PMID 31487743›Full record

ArticleIntervirology2019

Analytical Evaluation of the Human Papillomavirus HPV DNA Array E1-Based Genotyping Assay.

Aleksandra Pesic, Amrei Krings, Carola Schreckenberger, Matthias Hempel, Rosemarie Preyer, Andreas M Kaufmann

Open access · hybridAbstract readEvaluation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Intervirology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 37% 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.

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

4 citing papers in PubMed, 5 citations in OpenAlex.

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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

6 authors at 3 institutions in 1 country.

Aleksandra PesicGynaecology Clinic, Charité Universitätsmedizin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Berlin, Germany.
Amrei KringsGynaecology Clinic, Charité Universitätsmedizin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Berlin, Germany.
Carola SchreckenbergerGynaecology Clinic, Charité Universitätsmedizin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Berlin, Germany.
Matthias HempelAID/GenID Diagnostika, Strassberg, Germany.
Rosemarie PreyerAID/GenID Diagnostika, Strassberg, Germany.
Andreas M KaufmannGynaecology Clinic, Charité Universitätsmedizin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Berlin, Germany, andreas.kaufmann@charite.de.
Freie Universität Berlin · DEPathodiagnostik Berlin · DEHumboldt-Universität zu Berlin · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCervical cancer is caused by a persistent infection of human papillomavirus (HPV). Therefore, tests which detect the carcinogenic virus can be used for cervical cancer screening.

objectiveThis is the first evaluation of the HPV DNA Array (AID Diagnostika, Strassberg, Germany), an E1-based genotyping polymerase chain reaction (PCR) test for identification of 29 HPV types (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 44, 45, 51, 52, 53, 54, 56, 58, 59, 66, 67, 68, 69, 70, 73, 82, 85, and 97).

methodsAnalytical performance of the assay was assessed with cervical cancer cell lines with known HPV status, and preselected clinical cervical scrapings genotyped by multiplexed genotyping (MPG) with a Luminex readout (validated in-house assay). Intra- and inter-laboratory reproducibility experiments were performed to ensure the reliability of the assay.

resultsHPV DNA Array identified the intrinsic HPV genotype in all cervical cancer cell lines and demonstrated a high sensitivity for HPV16 probe (1 cell per PCR reaction), as well as HPV18 and 45 probes (100 cells per PCR reaction). When compared with MPG, HPV DNA Array showed a good agreement of 92.2% for HPV detection irrespective of type (κ = 0.601), and demonstrated high agreement for HPV16 (80.7%, κ = 0.836) and HPV18 (86.7%, κ = 0.925). Furthermore, high intra-/inter-laboratory reproducibility was observed (90.9-100%).

conclusionHPV DNA Array showed high sensitivity for correct HPV genotype detection in experimental and clinical samples with a good correlation to the reference test. Since HPV DNA Array is based on a simple multiplexed PCR followed by reverse hybridization in a 96-well format and automated visual readout by AID ELISpot reader, it is capable of high throughput in a time-effective manner. HPV DNA Array could be considered for extended HPV genotyping of cervical smears.

Indexed as

GenotypeCell Line, TumorGenotyping TechniquesHumansOligonucleotide Array Sequence AnalysisOncogene Proteins, ViralPapillomaviridaePapillomavirus InfectionsReproducibility of ResultsSensitivity and SpecificityOncogene Proteins, ViralCervical cancerGP5+/6+HPV detectionHuman papillomavirusLuminexMultiplexValidation

Identifiers

PMID31487743
PMCPMC6878751
OpenAlexW2972293719

What OpenQuestion holds

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Registered trials

None linked

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.