本文件提供了评估性能和确保质量的一般要求 用于量化特定核酸序列（靶点）的方法。 本文件适用于DNA（脱氧核糖核酸）和RNA（核糖核酸）的定量 使用数字（dPCR）或定量实时PCR（qPCR）扩增的acid）靶序列 技术。它适用于核酸分子中的靶序列，包括双链 DNA（双链DNA），如基因组DNA（gDNA）和质粒DNA，单链DNA（ssDNA）， 互补DNA（cDNA）和单链RNA（ssRNA），包括核糖体RNA（rRNA）， 信使RNA（mRNA）、长和短非编码RNA[小RNA（miRNA）和短 干扰RNA（siRNA）]，以及双链RNA（dsRNA）。 本文件适用于源于生物来源的核酸，如病毒、原核生物和生物 以及真核细胞、无细胞生物液体（例如血浆或细胞培养基）或体外来源[例如。 寡核苷酸、合成基因结构和体外转录（IVT）RNA]。 本文件不适用于非常短的DNA寡核苷酸（<50碱基）的定量。交叉引用:ISO/IEC指南99ISO/IEC指南98-3:2008ISO 20184-1ISO 20186-3ISO 20184-2ISO 16269-4ISO 17511ISO 24276ISO 20186-1ISO/IEC 17025ISO 21571ISO 5725-1ISO 20186-2ISO 13495:2013ISO 25720:2009ISO 15193:2009ISO 16577:2016购买本文件时提供的所有当前修订版均包括在内。

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 99ISO/IEC Guide 98-3:2008ISO 20184-1ISO 20186-3ISO 20184-2ISO 16269-4ISO 17511ISO 24276ISO 20186-1ISO/IEC 17025ISO 21571ISO 5725-1ISO 20186-2ISO 13495:2013ISO 25720:2009ISO 15193:2009ISO 16577:2016All current amendments available at time of purchase are included with the purchase of this document.