Guidance for the Validation of qPCR/dPCR Assays in Clinical Research
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Jan Hellemans CellCarta, Belgium |
Abstract
In 2019, the MIQE guidelines were published to provide a framework for the minimal information on qPCR experiments to be included in scientific articles. In doing so, it also guided researchers in the minimal optimization, characterization and validation efforts that would typically have to be conducted when developing or using a qPCR assay.
Higher quality standards do apply in the context of clinical trials and in vitro diagnostics. Except for ISO20395, regulatory requirements (e.g. IVDR 2017/746) and other guidelines (e.g. ICH) are however technology agnostic or typically lack specific references to PCR based assays. Reducing these guidelines to practice for qPCR or dPCR assay development and validation is therefore often quite a challenge.
In this presentation we therefore aim to frame the scale of varying quality assurance levels and to provide practical guidance on how to translate this into concrete qPCR or dPCR experiments to validate an assay for research or clinical research (trials) purposes.
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