ArticleGene therapy2016
Synthetic certified DNA reference material for analysis of human erythropoietin transgene and transcript in gene doping and gene therapy.
Article in Gene therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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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.
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Who cites it
11 citing papers in PubMed.
- Improvement of EPO Transgene Detection From Polymeric Dried Blood Spots for Antidoping Application.Drug testing and analysis · 2026Article
- Codon changes challenge PCR-based gene doping detection.Gene therapy · 2025Article
- Multiplex detection of seven transgenes for human gene doping analysis.Scientific reports · 2025Article
- Development of gene-in-plasmid DNA reference materials certified by single-molecule counting.Analytical and bioanalytical chemistry · 2025Article
- Administration and detection of a multi-target rAAV gene doping vector in horses using multiple matrices and molecular techniques.Gene therapy · 2024Article
- PCR-Based Equine Gene Doping Test for the Australian Horseracing Industry.International journal of molecular sciences · 2024Article
- Use of RNA biomarkers in the antidoping field.Bioanalysis · 2024Review
- Analysis of Potential Gene Doping Preparations for Transgenic DNA in the Context of Sports Drug Testing Programs.International journal of molecular sciences · 2023Article
- Screening for gene doping transgenes in horses via the use of massively parallel sequencing.Gene therapy · 2022Article
- Design and storage stability of reference materials for microfluidic quantitative PCR-based equine gene doping tests.Journal of equine science · 2021Article
- Development of a new genetic reference material system based onMolecular therapy. Methods & clinical development · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
There is a recognised need for standardisation of protocols for vector genome analysis used in vector manufacturing, to establish dosage, in biodistribution studies and to detect gene doping in sport. Analysis of vector genomes and transgene expression is typically performed by qPCR using plasmid-based calibrants incorporating transgenic sequences. These often undergo limited characterisation and differ between manufacturers, potentially leading to inaccurate quantification, inconsistent inter-laboratory results and affecting clinical outcomes. Contamination of negative samples with such calibrants could cause false positive results. We developed a design strategy for synthetic reference materials (RMs) with modified transgenic sequences to prevent false positives due to cross-contamination. When such RM is amplified in transgene-specific assays, the amplicons are distinguishable from transgene's amplicons based on size and sequence. Using human erythropoietin as a model, we produced certified RM according to this strategy and following ISO Guide 35. Using non-viral and viral vectors, we validated the effectiveness of this RM in vector genome analysis in blood in vitro. The developed design strategy could be applied to production of RMs for other transgenes, genes or transcripts. Together with validated PCR assays, such RMs form a measurement tool that facilitates standardised, accurate and reliable genetic analysis in various applications.
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Registered trials
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