DANSK DSF/ISO/FDIS 20395 PDF

This document provides generic guidelines for evaluating the performance and ensuring the quality of methods used for the quantification of specific nucleic acid sequences (targets). This will serve to ensure confidence in the data generated and demonstrate that a selected method is fit for its intended purpose. The document is applicable to the quantification of DNA and RNA target sequences using either digital (dPCR) or quantitative real-time PCR (qPCR) amplification technologies. It applies to target sequences present in nucleic acid molecules including double-stranded DNA (dsDNA) such as genomic DNA (gDNA) and plasmid DNA, single stranded DNA (ssDNA), complementary DNA (cDNA), and single stranded RNA (ssRNA) including ribosomal RNA (rRNA), messenger RNA (mRNA), and long and short non-coding RNA (microRNAs (miRNAs) and short interfering RNAs (siRNAs)), as well as double-stranded RNA (dsRNA). The document applies to nucleic acids derived from biological sources such as viruses, prokaryotic and eukaryotic cells, cell-free biological fluids (e.g. plasma or cell media) or in vitro sources (e.g. oligonucleotides, synthetic gene constructs and in vitro transcribed (IVT) RNA). This document is not applicable to quantification of very short oligonucleotides.