This document provides generic requirements for evaluating the performance and ensuring the quality of methods used for the quantification of specific nucleic acid sequences (targets).

This document is applicable to the quantification of DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) 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 doublestranded 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).

This 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 DNA oligonucleotides (<50 bases).

Cross References:
ISO/IEC Guide 99
ISO/IEC Guide 98-3:2008
ISO 20184-1
ISO 20186-3
ISO 20184-2
ISO 16269-4
ISO 17511
ISO 24276
ISO 20186-1
ISO/IEC 17025
ISO 21571
ISO 5725-1
ISO 20186-2
ISO 13495:2013
ISO 25720:2009
ISO 15193:2009
ISO 16577:2016


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