Evidence map›Paper›PMID 35632634›Full record

ArticleViruses2022

Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening.

Daniëlle A M Heideman, Anja Oštrbenk Valenčak, Saskia Doorn, Jesper Bonde, Peter Hillemanns, Grega Gimpelj Domjanič, Jana Mlakar, Albertus T Hesselink, Chris J L M Meijer, Mario Poljak

Open access · goldAbstract read
In one paragraph

Article in Viruses, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 33% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. 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

10 authors at 4 institutions in 4 countries.

Daniëlle A M HeidemanDepartment of Pathology, Amsterdam UMC Location Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 Amsterdam, The Netherlands.ORCID 0000-0001-6463-7391
Anja Oštrbenk ValenčakInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, Slovenia.
Saskia DoornSelf-Screen, 1081 Amsterdam, The Netherlands.
Jesper BondeMolecular Pathology Laboratory, Department of Pathology, Hvidovre Hospital, 2650 Hvidovre, Denmark.
Peter HillemannsDepartment of Gynecology and Obstetrics, Hannover Medical School, 30625 Hannover, Germany.ORCID 0000-0001-9829-3531
Grega Gimpelj DomjaničInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, Slovenia.
Jana MlakarInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, Slovenia.
Albertus T HesselinkSelf-Screen, 1081 Amsterdam, The Netherlands.
Chris J L M MeijerDepartment of Pathology, Amsterdam UMC Location Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 Amsterdam, The Netherlands.
Mario PoljakInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, Slovenia.ORCID 0000-0002-3216-7564
University of Ljubljana · SIAmsterdam University Medical Centers · NLHvidovre Hospital · DKMedizinische Hochschule Hannover · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The NeuMoDx HPV assay is a novel fully automated, real-time PCR-based assay for the qualitative detection of high-risk human papillomavirus (HPV) DNA in cervical specimens. The assay specifically identifies HPV16 and HPV18 and concurrently detects 13 other high-risk HPV types at clinically relevant infection levels. Following the international guidelines, the clinical performance of the NeuMoDx HPV assay for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) against the reference standard Hybrid Capture 2, as well as intra- and inter-laboratory reproducibility were assessed on PreservCyt samples. The clinical accuracy of the assay was additionally evaluated against the clinically validated Alinity m HR HPV and COBAS 4800 HPV Test on PreservCyt samples, and against the clinically validated HPV-Risk assay on SurePath samples. The NeuMoDx HPV assay performance for CIN2+ was non-inferior to the reference methods on both sample types (all p < 0.05), and showed excellent intra- and inter-laboratory reproducibility (95.7%; 95% CI: 93.9−97.3; kappa value 0.90 (95% CI: 0.86−0.94); and 94.5%; 95% CI: 92.6−96.2; kappa value 0.87 (95% CI: 0.82−0.92), respectively). In conclusion, the NeuMoDx HPV assay meets international guideline criteria for cross-sectional accuracy and reproducibility, and performs equally well on cervical screening specimens collected in two widely used collection media. The NeuMoDx HPV assay fulfils the requirements to be used for primary cervical screening.

Indexed as

Papillomavirus InfectionsUterine Cervical NeoplasmsCross-Sectional StudiesEarly Detection of CancerFemaleHumansPapillomaviridaeReproducibility of ResultsSensitivity and Specificitycervical cancer screeningclinical performancehuman papillomavirusliquid mediumNeuMoDx HPV Test Stripreproducibility

Identifiers

PMID35632634
PMCPMC9143392
OpenAlexW4224434559

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.