Abstract

This standard would provide general requirements and guidance for the development and application of LAMP-based methods for the detection of microorganisms and associated genetic markers sampled along the food chain (e.g., ingredients, human food, animal food, and the production environment), and includes sample preparation, isothermal amplification, signal detection, data interpretation, and performance criteria. This standard would also define laboratory and data management practices to ensure that LAMP methods are performed accurately, and data are reported clearly for end users and stakeholders. Out of scope - LAMP methods applied for non-food (medical/veterinary) use. Purpose and justification of the proposal There are currently no standards available today for loop-mediated isothermal amplification (LAMP) methods for the detection of microorganisms in the food chain, and yet these methods are commonly used today for this purpose, and often as methods of choice by global government agencies and the industry. Recently published, was an ISO standard on isoPCR (ISO 22942-1:2022 Molecular biomarker analysis - Isothermal polymerase chain reaction [isoPCR] methods - Part 1: General requirement) was published by ISO TC34/SC16 (Horizontal methods for molecular biomarker analysis). This standard is a high-level horizontal standard for isoPCR technologies in general and not specific to LAMP. Annex D (1.5 pages within the standard) is designated for LAMP methods, but this Annex is labelled as informative. This Annex does not provide sufficient detail for food and feed microbiology methods to be normative; nor does it cover both detection and quantification of microorganisms in feed and food using LAMP methods. Additionally, there is some confusion within the food and feed production industry on the applicability of a PCR standard (ISO-CD 22174:202X Microbiology of the food chain -Polymerase chain reaction [PCR] for the detection and quantification of microorganisms - General requirements and definitions) currently under development within ISO TC34/SC9/WG3 to LAMP-based pathogen detection methods. The proposed standard will not be applicable to LAMP-based methods by definition. Recent inquiries from users of commercial LAMP test methods to confirm that LAMP methods will meet the proposed ISO CD 22174:202X PCR standard criteria, indicate that the scope of this standard is not well understood. Creating an analogous standard for LAMP methods will help ensure the creation of requirements appropriate for LAMP methods and will help to alleviate this confusion. The development of an ISO standard for LAMP methods for detection of microorganisms within the food chain would help to define general requirements for these methods, which in turn would provide increased confidence and recognition for the use of these methods.

Begin

2024-03-05

WI

00463112

Planned document number

DIN EN ISO 24914

Project number

05702721

Responsible national committee

NA 057-01-06 AA - Microbiology of the food chain  

Responsible european committee

CEN/TC 463 - Microbiology of the food chain  

Responsible international committee

ISO/TC 34/SC 9/WG 36 - General requirements relating to LAMP-based methods