What is ISO 20395 - Performance of quantification method for qPCR and dPCR about?
ISO 20395 discusses biotechnology. ISO 20395 is an international standard on performance evaluation of quantification methods for nucleic acid target sequences — qPCR and dPCR in biotechnology.
ISO 20395 details generic requirements for evaluating the performance and ensuring the quality of methods used for the quantification of specific nucleic acid sequences (targets).
ISO 20395 specifies:
Analytical design including quantification strategies and use of controls
Quantification of total nucleic acid mass concentration and quality control of a nucleic acid sample including assessment of nucleic acid quality (purity and integrity)
PCR assay design, optimization, in silico and in vitro specificity testing
Data quality control and analysis including acceptance criteria, threshold setting and normalization
Method validation with specific requirements for qPCR and dPCR
Approaches to establishing metrological traceability and estimating measurement uncertainty
ISO 20395 applies to the quantification of DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) target sequences, using either digital (dPCR) or quantitative real-time PCR (qPCR) amplification technol...