Standards Development

Scope

This document specifies the general requirements and provides guidance for the development and application of loop-mediated isothermal amplification (LAMP) to detect microorganisms and associated genetic markers (e.g. antimicrobial resistance genes, virulence genes) in the food chain. This document is applicable to all LAMP methods, platforms, items from food chain and laboratories. The use of LAMP for quantification is out of scope for this document.

Validation and verification of LAMP methods as either alternative or reference methods are not covered in this document. Both validation and verification of microbiological methods are discussed in detail in the ISO 16140 series and ISO 17468.

General requirements for isothermal methods including LAMP for molecular biomarker analysis are covered by ISO 22942-1, and general requirements and definitions for polymerase chain reaction (PCR) for the detection and quantification of microorganisms in the food chain are covered by ISO 22174.

This document has been established for microorganisms in the food chain and is applicable to:

— 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 for the above items.