Standards Development

Scope

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, 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).