ISO/WD 12833

Biotechnology — Requirements for RNA quantification methods for gene expression analysis of biological and bioengineered systems

Scope

This document supports the field of biotechnology and engineering biology and provides general requirements for evaluating the performance, and ensuring the quality of methods used, for the detection and quantification of RNA for gene expression analysis of biological and bioengineered systems.
This document applies to RNA derived from biological systems including bacterial, yeast, plant, and mammalian cells, as well as cell-free systems. It covers quantification strategies, sample handling and processing requirements, method validation, data analysis and reporting.
It is applicable to methods requiring RNA extraction/purification from the system of interest and covers targeted analysis of gene expression using approaches such as PCR, and wider transcriptome analysis using approaches such as sequencing and microarrays.
The focus of the document is on RNA quantification for gene expression analysis, but aspects may also apply to other applications requiring RNA quantification such as encapsulated mRNA characterization.
The document excludes methods that do not require extraction of RNA from the biological system such as Fluorescent In-situ Hybridization (FISH) and also excludes electrophoretic methods such as Northern blotting.
This document serves developers of products and processes based on the use of biological and bioengineered systems in biotechnology and engineering biology applications for use across multiple biotechnology sectors.