Ehdotuksen tiedot

This document specifies minimum requirements of performance characteristics for the detection and quantification of nucleic acid sequences (DNA or RNA) by PCR-based assays. The PCR-based assays specified in this document do not include culturing and nucleic acid extraction stages. NOTE ISO 22174:2024 [5], clause 13, states that this document specifies the performance characteristics for PCR-based methods. To differentiate from complete methods, which are evaluated according to validation standards such as the ISO 16140 series, the term "PCR-based assay" is used in this document. This document applies to the detection and/or quantification of nucleic acids of microorganisms (bacteria, yeasts, moulds, viruses and protozoan parasites) associated with: products intended for human consumption; products for feeding animals; environmental samples in the area of food and feed production and handling; samples from the primary production stage. This document, or parts of it, is also applicable to other fields of PCR diagnostics based on a case-by-case evaluation. This document does not apply to sequencing methods or isothermal amplification methods like loop mediated amplification (LAMP) or nucleic acid sequence-based amplification (NASBA).