Biotechnology. Requirements for evaluating the performance of quantification methods for nucleic acid target sequences. qPCR and dPCR Ingestion-build-47182

Biotechnology. Requirements for evaluating the performance of quantification methods for nucleic acid target sequences. qPCR and dPCR Ingestion-build-471821 Scope 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

This test may also be used for similar devices when specified in a detailed specification

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