Evidence map›Paper›PMID 31438976›Full record

ArticleVirology journal2019

Clinical validation of the HPVIR high-risk HPV test on cervical samples according to the international guidelines for human papillomavirus DNA test requirements for cervical cancer screening.

Inger Gustavsson, Riina Aarnio, Mattias Myrnäs, Julia Hedlund-Lindberg, Ongeziwe Taku, Tracy Meiring, Ingrid Wikström, Stefan Enroth, Anna-Lise Williamson, Matts Olovsson and 1 more

Open access · goldAbstract readEvaluation StudyValidation 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 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.9field-weighted citation impact, top 9% 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

15 citing papers in PubMed, 29 citations in OpenAlex.

  1. Article
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  4. History of HPV in HPV-positive elderly women.European journal of obstetrics & gynecology and reproductive biology: X · 2024
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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

11 authors at 2 institutions in 2 countries.

Inger GustavssonDepartment of Immunology, Genetics, and Pathology, Biomedical Center, Science for Life Laboratory Uppsala, Uppsala University, Box 815, SE-75108, Uppsala, Sweden.
Riina AarnioDepartment of Women's and Children's Health, Uppsala University, SE-751 85, Uppsala, Sweden.
Mattias MyrnäsDepartment of Women's and Children's Health, Uppsala University, SE-751 85, Uppsala, Sweden.
Julia Hedlund-LindbergDepartment of Immunology, Genetics, and Pathology, Biomedical Center, Science for Life Laboratory Uppsala, Uppsala University, Box 815, SE-75108, Uppsala, Sweden.
Ongeziwe TakuDivision of Medical Virology, Faculty of Health Sciences, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.
Tracy MeiringDivision of Medical Virology, Faculty of Health Sciences, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.
Ingrid WikströmDepartment of Women's and Children's Health, Uppsala University, SE-751 85, Uppsala, Sweden.
Stefan EnrothDepartment of Immunology, Genetics, and Pathology, Biomedical Center, Science for Life Laboratory Uppsala, Uppsala University, Box 815, SE-75108, Uppsala, Sweden.
Anna-Lise WilliamsonDivision of Medical Virology, Faculty of Health Sciences, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.
Matts OlovssonDepartment of Women's and Children's Health, Uppsala University, SE-751 85, Uppsala, Sweden.
Ulf GyllenstenDepartment of Immunology, Genetics, and Pathology, Biomedical Center, Science for Life Laboratory Uppsala, Uppsala University, Box 815, SE-75108, Uppsala, Sweden. ulf.gyllensten@igp.uu.se.ORCID 0000-0002-6316-3355
Uppsala University · SEUniversity of Cape Town · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe indicating FTA card is a dry medium used for collection of cervical samples. HPVIR is a multiplex real-time PCR test that detects 12 high-risk human papillomavirus types (hrHPV) and provides single genotype information for HPV16, - 31, - 35, - 39, - 51, - 56, and - 59 and pooled type information for HPV18/45 and HPV33/52/58. The aim of this study was to evaluate whether a strategy with cervical samples collected on the FTA card and subsequently analysed with the HPVIR test complies with the criteria of the international guidelines for a clinically validated method for cervical screening.

methodsWe performed a non-inferiority test comparing the clinical sensitivity and specificity of the candidate test (FTA card and HPVIR) with a clinically validated reference test (Cobas

resultsThe clinical sensitivity and specificity for samples collected on the FTA card and analysed using the HPVIR test were non-inferior to samples analysed with the Cobas® HPV test based on LBC samples (non-inferiority test score, p = 1.0 × 10

conclusionsSamples collected on the indicating FTA card and analysed with HPVIR test fulfil the requirements of the international guidelines and can therefore be used in primary cervical cancer screening.

Indexed as

AdultAlphapapillomavirusCervix UteriDNA, ViralEarly Detection of CancerFemaleGenotypeHuman Papillomavirus DNA TestsHumansMass ScreeningMiddle AgedPapillomavirus InfectionsPractice Guidelines as TopicReproducibility of ResultsSensitivity and SpecificitySpecimen HandlingDNA, ViralDNA testingHPVInternational guidelinesPrimary cervical cancer screening

Identifiers

PMID31438976
PMCPMC6704622
OpenAlexW2969230295

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.