Consensus guidelines for the validation of qRT-PCR assays in clinical research by the CardioRNA consortium.
PCR
RNA
assay validation
clinical research assays
noncoding RNA
Journal
Molecular therapy. Methods & clinical development
ISSN: 2329-0501
Titre abrégé: Mol Ther Methods Clin Dev
Pays: United States
ID NLM: 101624857
Informations de publication
Date de publication:
10 Mar 2022
10 Mar 2022
Historique:
entrez:
4
2
2022
pubmed:
5
2
2022
medline:
5
2
2022
Statut:
epublish
Résumé
Despite promising findings, quantitative PCR (qPCR)-based tests for RNA quantification have experienced serious limitations in their clinical application. The noticeable lack of technical standardization remains a huge obstacle in the translation of qPCR-based tests. The incorporation of qPCR-based tests into the clinic will benefit from guidelines for clinical research assay validation. This will ultimately impact the clinical management of the patient, including diagnosis, prognosis, prediction, monitoring of the therapeutic response, and evaluation of toxicity. However, clear assay validation protocols for biomarker investigation in clinical trials using molecular assays are currently lacking
Identifiants
pubmed: 35118162
doi: 10.1016/j.omtm.2021.12.007
pii: S2329-0501(22)00001-8
pmc: PMC8792405
doi:
Types de publication
Journal Article
Review
Langues
eng
Pagination
171-180Informations de copyright
© 2022 The Authors.
Déclaration de conflit d'intérêts
D.d.G.-C. holds a patent on miRNAs as biomarkers. Y.D. holds patents related to diagnostic and therapeutic applications of RNAs. The other authors declare no competing interests.
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