ArticleJournal of clinical laboratory analysis2019
Intra- and inter-laboratory agreement of the FAM19A4/mir124-2 methylation test: Results from an international study.
Article in Journal of clinical laboratory analysis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
What it found
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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.
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.
Who cites it
23 citing papers in PubMed, 32 citations in OpenAlex.
- Triage Performance of FAM19A4/miR124-2 Methylation: 18-Month Follow-Up Results From a Prospective Observational Study Within the Dutch Primary HPV-Based Cervical Screening Program.International journal of cancer · 2026Observational
- Observational
- Diagnostic Accuracy of DNA Methylation Markers for Detecting Cervical Precancer and Cervical Cancer: A Systematic Review and Meta-analysis.Archives of academic emergency medicine · 2026Review
- Evaluating the Predictive Performance of miR-124-2 and FAM19A4 for Cervical Lesions in a Single Center from Romania: A Prospective Study.Journal of clinical medicine · 2025Article
- Triage performance of DNA methylation for women with high-risk human papillomavirus infection.The oncologist · 2025Article
- Human papillomavirus-mediated cervical cancer: epigenetic interplay and clinical implications.Frontiers in microbiology · 2025Review
- DNA methylation as a triage tool for cervical cancer screening - A meeting report.Preventive medicine reports · 2024Review
- HPV testing in Polish population-based cervical cancer screening programme (HIPPO project)-study protocol of a randomised healthcare policy trial.BMC cancer · 2023Article
- Evaluation of DNA methylation biomarkers ASCL1 and LHX8 on HPV-positive self-collected samples from primary HPV-based screening.British journal of cancer · 2023Article
- NOVAprep-miR-Cervix: New Method for Evaluation of Cervical Dysplasia Severity Based on Analysis of Six miRNAs.International journal of molecular sciences · 2023Article
- FAM19A4/miR124-2 Methylation Testing and Human Papillomavirus (HPV) 16/18 Genotyping in HPV-Positive Women Under the Age of 30 Years.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Article
- Epigenetic and Transcriptomic Regulation Landscape in HPV+ Cancers: Biological and Clinical Implications.Frontiers in genetics · 2022Review
- Detection of Host Cell Gene/HPV DNA Methylation Markers: A Promising Triage Approach for Cervical Cancer.Frontiers in oncology · 2022Review
- Classification of high-grade cervical intraepithelial neoplasia by p16International journal of cancer · 2021Article
- The use of host cell DNA methylation analysis in the detection and management of women with advanced cervical intraepithelial neoplasia: a review.BJOG : an international journal of obstetrics and gynaecology · 2021Review
- Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women: A large European multicenter study.International journal of cancer · 2021Article
- MicroRNA-Based Fingerprinting of Cervical Lesions and Cancer.Journal of clinical medicine · 2020Review
- FAM19A4/miR124-2 methylation in invasive cervical cancer: A retrospective cross-sectional worldwide study.International journal of cancer · 2020Article
- Current status of development of methylation biomarkers for in vitro diagnostic IVD applications.Clinical epigenetics · 2020Review
Corrections and comments
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Authors and funding
16 authors at 8 institutions in 5 countries.
Funding
Abstract
backgroundHPV-based cervical screening detects women at an increased risk of cervical cancer and precancer. To differentiate among HPV-positive women those with (pre)cancer, triage testing is necessary. The detection of cancer-associated host-cell DNA methylation (FAM19A4 and hsa-mir124-2) in cervical samples has shown valuable as triage test. This multicenter study from 6 collaborating European laboratories and one reference laboratory was set out to determine the intra- and inter-laboratory agreement of FAM19A4/mir124-2 DNA methylation analysis utilizing the QIAsure Methylation Test.
methodsAgreement analysis for the QIAsure Methylation Test was assessed on high-risk HPV-positive cervical specimens (n = 1680) both at the level of the assay and at the full workflow, including bisulfite conversion.
resultsIntra- and inter-laboratory assay agreement were 91.4% (534/584; 95% CI 88.9-93.5; κ = 0.82) and 92.5% (369/399; 95% CI 90.0-94.7; κ = 0.83), respectively. The inter-laboratory workflow (bisulfite conversion and assay combined) agreement was 90.0% (627/697; 95% CI 87.5%-92.0%; κ = 0.76).
conclusionThese data show that the QIAsure Methylation Test performs robust and reproducible in different laboratory contexts. These results support the use of the QIAsure Methylation Test for full molecular screening for cervical cancer, including primary HPV testing and triage testing by methylation analysis.
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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.