EN ISO 24914:2026
(Main)Microbiology of the food chain - Loop-mediated isothermal amplification (LAMP) for the detection of microorganisms and associated genetic markers - General requirements and definitions (ISO 24914:2026)
Microbiology of the food chain - Loop-mediated isothermal amplification (LAMP) for the detection of microorganisms and associated genetic markers - General requirements and definitions (ISO 24914:2026)
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, and items from the food chain and laboratories.
This document does not apply to the use of LAMP for quantification.
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 described in detail in the ISO 16140 series and ISO 17468.
General requirements for isothermal methods including LAMP for molecular biomarker analysis are given in 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 given in 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.
Mikrobiologie der Lebensmittelkette - Loop-mediated isothermal amplification (LAMP) zum Nachweis von Mikroorganismen - Allgemeine Anforderungen und Leitlinien (ISO 24914:2026)
Microbiologie de la chaîne alimentaire - Amplification isotherme à médiation par boucle (LAMP) pour la détection de micro-organismes et de marqueurs génétiques associés - Exigences générales et définitions (ISO 24914:2026)
Le présent document spécifie les exigences générales et fournit des recommandations concernant la mise au point et l’application de l’amplification isotherme à médiation par boucle (LAMP) pour la détection de micro-organismes et de marqueurs génétiques associés (par exemple, gènes de résistance aux antimicrobiens, gènes de virulence) dans la chaîne alimentaire.
Le présent document est applicable à l’ensemble des méthodes par LAMP, des plateformes, et des produits de la chaîne alimentaire et des laboratoires.
Le présent document ne s’applique pas à l’utilisation de la LAMP à des fins de quantification.
La validation et la vérification des méthodes par LAMP comme méthodes alternatives ou de référence ne sont pas couvertes dans le présent document. La validation et la vérification des méthodes microbiologiques sont toutes deux décrites en détail dans la série de normes ISO 16140 et l’ISO 17468.
Les exigences générales applicables aux méthodes isothermes, dont la LAMP, pour l’analyse de biomarqueurs moléculaires sont données dans l’ISO 22942-1, et les exigences générales et définitions relatives à la réaction de polymérisation en chaîne (PCR) pour la détection et la quantification de micro-organismes dans la chaîne alimentaire sont données dans l’ISO 22174.
Le présent document a été conçu pour les micro-organismes rencontrés dans la chaîne alimentaire et s’applique aux:
— produits destinés à la consommation humaine;
— produits destinés à l’alimentation animale;
— échantillons environnementaux prélevés dans les secteurs de la production et de la distribution des aliments destinés à la consommation humaine et l’alimentation animale;
— échantillons prélevés au stade de la production primaire des produits susmentionnés.
Mikrobiologija v prehranski verigi - Z zanko posredovana izotermna amplifikacija (LAMP) za ugotavljanje prisotnosti mikroorganizmov in njim pripadajočih genetskih označevalcev - Splošne zahteve in definicije (ISO 24914:2026)
General Information
- Status
- Published
- Publication Date
- 20-Jan-2026
- Technical Committee
- CEN/TC 463 - Microbiology of the food chain
- Drafting Committee
- CEN/TC 463 - Microbiology of the food chain
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 21-Jan-2026
- Due Date
- 08-Dec-2026
- Completion Date
- 21-Jan-2026
Overview
FprEN ISO 24914 / ISO/FDIS 24914:2025 provides general requirements and definitions for the use of loop-mediated isothermal amplification (LAMP) to detect microorganisms and associated genetic markers in the food chain. The standard covers end-to-end aspects of LAMP testing for food- and feed-related samples - including ingredients, human food, animal feed and production-environment samples - and sets expectations for sample preparation, nucleic acid extraction, isothermal amplification, signal detection, data interpretation, reporting, laboratory practices and data management.
Note: this document is focused on food-chain applications. LAMP methods for non-food medical or veterinary use, and quantitative LAMP, are out of scope.
Key Topics
- Scope and definitions: clear definitions for LAMP terminology and applicability across food-chain matrices.
- Workflow guidance: recommendations for sample preparation, nucleic acid extraction and isothermal amplification procedures without prescribing specific kit protocols.
- Signal detection & interpretation: accepted approaches for detecting LAMP amplicons and interpreting control and test results for reliable reporting.
- Performance criteria: high-level performance characteristics to guide method development and routine testing (sensitivity, specificity considerations).
- Laboratory setup & safety: segregation of pre‑ and post‑amplification areas, contamination control measures and general biosafety guidance.
- Controls and quality management: use of positive extraction controls, internal/external amplification controls and guidance on control interpretation.
- Reagents, consumables & equipment: general requirements for isothermal instruments, detection systems and laboratory consumables.
- Data management and reporting: practices to ensure accurate, transparent reporting of LAMP results to stakeholders.
Applications
Who will use this standard:
- Food industry laboratories performing routine screening for pathogens, virulence factors or antimicrobial-resistance markers.
- Regulatory and public-health laboratories implementing LAMP methods for surveillance of food and feed.
- Academic researchers developing LAMP assays for food microbiology applications.
- Test kit and instrument manufacturers aligning product design with food-chain requirements.
Practical applications include rapid on-site screening, environmental monitoring in food production, ingredient testing and targeted detection of genetic markers linked to food safety risks.
Related Standards
- ISO 22174 - PCR general requirements and definitions (related molecular method guidance)
- ISO 22942-1 - General requirements for isothermal methods (broader context)
- ISO 16140 series and ISO 17468 - Method validation and verification guidance (for formal validation)
- ISO 6887 & ISO 7218 - Sample preparation and microbiological laboratory practice
Keywords: LAMP, loop-mediated isothermal amplification, food microbiology, ISO 24914, detection of microorganisms, genetic markers, food chain, sample preparation, nucleic acid extraction, isothermal amplification, signal detection, data interpretation.
Frequently Asked Questions
EN ISO 24914:2026 is a standard published by the European Committee for Standardization (CEN). Its full title is "Microbiology of the food chain - Loop-mediated isothermal amplification (LAMP) for the detection of microorganisms and associated genetic markers - General requirements and definitions (ISO 24914:2026)". This standard covers: 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, and items from the food chain and laboratories. This document does not apply to the use of LAMP for quantification. 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 described in detail in the ISO 16140 series and ISO 17468. General requirements for isothermal methods including LAMP for molecular biomarker analysis are given in 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 given in 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.
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, and items from the food chain and laboratories. This document does not apply to the use of LAMP for quantification. 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 described in detail in the ISO 16140 series and ISO 17468. General requirements for isothermal methods including LAMP for molecular biomarker analysis are given in 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 given in 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.
EN ISO 24914:2026 is classified under the following ICS (International Classification for Standards) categories: 07.100.30 - Food microbiology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 24914:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2026
Mikrobiologija v prehranski verigi - Z zanko posredovana izotermna amplifikacija
(LAMP) za ugotavljanje prisotnosti mikroorganizmov in njim pripadajočih
genetskih označevalcev - Splošne zahteve in definicije (ISO 24914:2026)
Microbiology of the food chain - Loop-mediated isothermal amplification (LAMP) for the
detection of microorganisms and associated genetic markers - General requirements
and definitions (ISO 24914:2026)
Mikrobiologie der Lebensmittelkette - Loop-mediated isothermal amplification (LAMP)
zum Nachweis von Mikroorganismen - Allgemeine Anforderungen und Leitlinien (ISO
24914:2026)
Microbiologie de la chaîne alimentaire - Amplification isotherme à médiation par boucle
(LAMP) pour la détection de micro-organismes et de marqueurs génétiques associés -
Exigences générales et définitions (ISO 24914:2026)
Ta slovenski standard je istoveten z: EN ISO 24914:2026
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 24914
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2026
EUROPÄISCHE NORM
ICS 07.100.30
English Version
Microbiology of the food chain - Loop-mediated isothermal
amplification (LAMP) for the detection of microorganisms
and associated genetic markers - General requirements
and definitions (ISO 24914:2026)
Microbiologie de la chaîne alimentaire - Amplification Mikrobiologie der Lebensmittelkette - Loop-mediated
isotherme à médiation par boucle (LAMP) pour la isothermal amplification (LAMP) zum Nachweis von
détection de micro-organismes et de marqueurs Mikroorganismen - Allgemeine Anforderungen und
génétiques associés - Exigences générales et définitions Leitlinien (ISO 24914:2026)
(ISO 24914:2026)
This European Standard was approved by CEN on 9 January 2026.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 24914:2026 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 24914:2026) has been prepared by Technical Committee ISO/TC 34 "Food
products" in collaboration with Technical Committee CEN/TC 463 “Microbiology of the food chain” the
secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by July 2026, and conflicting national standards shall be
withdrawn at the latest by July 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 24914:2026 has been approved by CEN as EN ISO 24914:2026 without any modification.
International
Standard
ISO 24914
First edition
Microbiology of the food chain —
2026-01
Loop-mediated isothermal
amplification (LAMP) for the
detection of microorganisms
and associated genetic markers
— General requirements and
definitions
Microbiologie de la chaîne alimentaire — Amplification
isotherme à médiation par boucle (LAMP) pour la détection
de micro-organismes et de marqueurs génétiques associés —
Exigences générales et définitions
Reference number
ISO 24914:2026(en) © ISO 2026
ISO 24914:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 24914:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Principle . 3
4.1 General .3
4.2 Laboratory procedure .4
4.3 Data interpretation .4
4.4 Performance criteria .4
5 General laboratory guidance . 4
5.1 General .4
5.2 Laboratory setup .5
5.3 Use of controls .5
5.3.1 General .5
5.3.2 Positive extraction control .6
5.3.3 Internal/external amplification control .6
6 Reagents and consumables . 6
7 Equipment . 7
8 Laboratory procedure . 7
8.1 General .7
8.2 Sample preparation .7
8.3 Nucleic acid extraction .7
8.4 Isothermal amplification .8
8.5 Signal detection .8
9 Data interpretation . 8
9.1 General .8
9.2 Interpretation of controls .8
9.3 Interpretation of test portion results .9
9.4 Test report .9
10 Performance characteristics . 9
Annex A (informative) LAMP basics . 10
Bibliography .16
iii
ISO 24914:2026(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 9,
Microbiology, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 463, Microbiology of the food chain, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO 24914:2026(en)
Introduction
Loop-mediated isothermal amplification (LAMP) is used for the detection of microorganisms and associated
genetic markers (e.g. antimicrobial resistance genes, virulence genes) in the food chain. LAMP is a robust
[10][11][12]
nucleic acid amplification technique with minimum requirements for nucleic acid extraction.
[13][14]
Some LAMP assays can use extraction-free samples. Many LAMP assays are designed to provide
extraction and analysis in the same chamber/container (e.g. tube) for ease of use. LAMP requires minimal
instrumentation. Some LAMP instruments are battery operated and may be used in a non-laboratory field
setting. This document provides the 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, the production environment), and includes sample
preparation, nucleic acid extraction, isothermal amplification, signal detection, data interpretation, report
generation and performance criteria. This document can be used by academia, industry and regulatory
bodies for developing and applying LAMP methods for the detection of microorganisms and associated
genetic markers in the food chain.
v
International Standard ISO 24914:2026(en)
Microbiology of the food chain — Loop-mediated isothermal
amplification (LAMP) for the detection of microorganisms
and associated genetic markers — General requirements and
definitions
WARNING — In order to protect the health and safety of laboratory personnel and the environment, it
is essential that tests for the detection of microorganisms are only undertaken in properly equipped
laboratories and under the control of skilled laboratory personnel. Appropriate precautions shall
be taken in the disposal of all samples and cultured materials. Persons using this document shall
be familiar with normal laboratory safety practices. This document does not purport to address all
of the health and safety aspects, if any, associated with its use. It is the responsibility of the user to
establish appropriate health and safety practices.
1 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, and items from the food chain and laboratories.
This document does not apply to the use of LAMP for quantification.
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 described in detail in the
ISO 16140 series and ISO 17468.
General requirements for isothermal methods including LAMP for molecular biomarker analysis are given in
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 given in 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 6887 (all parts), Microbiology of the food chain — Preparation of test samples, initial suspension and
decimal dilutions for microbiological examination
ISO 7218, Microbiology of the food chain — General requirements and guidance for microbiological examinations
ISO 16140 (all parts), Microbiology of the food chain — Method validation
ISO 24914:2026(en)
ISO 20836:2021, Microbiology of the food chain — Polymerase chain reaction (PCR) for the detection of
microorganisms — Thermal performance testing of thermal cyclers
ISO 22118:2011, Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the
detection and quantification of food-borne pathogens — Performance characteristics
ISO 22174:2024, Microbiology of the food chain — Polymerase chain reaction (PCR) for the detection and
quantification of microorganisms — General requirements and definitions
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
loop-mediated isothermal amplification
LAMP
isothermal nucleic acid amplification technique that relies on auto-cycling strand-displacement
deoxyribonucleic acid (DNA) synthesis that is performed by a strand-displacing DNA polymerase (3.3) and
a set of two specially designed inner and two outer primers to form a stem-loop DNA structure during
initiation steps, which serves as the starting material for second-stage LAMP cycling where a set of two
(sometimes one) loop primers may be added to speed up amplification
3.2
reverse transcription-loop-mediated isothermal amplification
RT-LAMP
method consisting of two reactions, a reverse transcription (RT) of ribonucleic acid (RNA) to single-stranded
complementary deoxyribonucleic acid (cDNA), followed by a loop-mediated isothermal amplification (LAMP)
(3.1)
Note 1 to entry: One-step RT-LAMP is performed in a single tube.
Note 2 to entry: Two-step RT-LAMP can either be performed sequentially in a single tube or in two different tubes.
[SOURCE: ISO 22174:2024, 3.3.3, modified — “LAMP” replaced “PCR” in the term name, definition and notes
to entry.]
3.3
strand-displacing DNA polymerase
deoxyribonucleic acid (DNA) polymerase used for DNA amplification characterized by DNA template-
dependent 5′→3′ polymerase activity and strand displacement activity at a single elevated temperature (e.g.
between 60 °C and 65 °C), that also lacks 5′→3′ exonuclease activity
Note 1 to entry: Strand-displacing DNA polymerase is commonly used for DNA amplification by LAMP.
3.4
positive extraction control
sample, spiked with a microorganism, treated in the same way as the test samples from extraction to
amplification to monitor the extraction process
[SOURCE: ISO 22174:2024, 3.5.2, modified — “extraction” replaced “process” in the term. “from extraction to
amplification to monitor the extraction process” replaced “to monitor the entire process of the polymerase-
chain-reaction-based method” in the definition.]
ISO 24914:2026(en)
3.5
internal amplification control
nucleic acid added to each reaction in a defined amount or copy number which serves as an internal control
for amplification
Note 1 to entry: This nucleic acid sequence can be endogenous (naturally present in the tested matrix) or exogenous
(naturally absent in the tested matrix).
Note 2 to entry: An exogenous internal amplification control can be homologous (amplified using the same primers
as used for amplification of the target) or heterologous (amplified using different primers than those used for
amplification of the target). A homologous internal amplification control amplicon shall be distinguishable from the
microbial target amplicon (e.g. by melting temperature).
[SOURCE: ISO 22174:2024, 3.5.5, modified — “by melting temperature” replaced “by size or by insertion of a
different probe-binding sequence” in Note 2 to entry.]
3.6
positive loop-mediated isothermal amplification control
positive LAMP control
loop-mediated isothermal amplification (LAMP) (3.1) reaction containing the target nucleic acid in a defined
amount or copy number
[SOURCE: ISO 22174:2024, 3.5.7, modified — “LAMP” replaced “PCR” in the term name. “loop-mediated
isothermal amplification (LAMP)” added in the definition.]
3.7
negative loop-mediated isothermal amplification control
negative LAMP control
no-template control
NTC
loop-mediated isothermal amplification (LAMP) (3.1) control made with water (or other LAMP-inert substrate
such as elution buffer) free of target nucleic acid and LAMP inhibitors (3.8)
[SOURCE: ISO 22174:2024, 3.5.8, modified — “LAMP” replaced “PCR” in the term name and definition.
Admitted term added. “grinding or” deleted in the definition.]
3.8
loop-mediated isothermal amplification inhibitor
LAMP inhibitor
component of the test portion that negatively interferes with the nucleic acid amplification of loop-mediated
isothermal amplification (LAMP) (3.1) resulting in a null or partial amplification of the nucleic acid target, or
that reduces signal generation
EXAMPLE Bile salts, calcium chloride, humic acid.
3.9
non-laboratory field setting
workspace lacking conditions controlled for environmental aerosol contamination and sophisticated nucleic
acid purification apparatus
[SOURCE: ISO 16577:2022, 3.3.42]
4 Principle
4.1 General
The procedure comprises the following consecutive steps:
a) sample preparation, if required;
b) nucleic acid extraction, if required;
ISO 24914:2026(en)
c) isothermal amplification;
d) signal detection;
e) data interpretation.
4.2 Laboratory procedure
Sampling is out of scope for this document. For general instructions on sampling, see ISO 7218. Further
details of sampling certain products are given in specific standards (e.g. ISO/TS 17728, ISO 17604, ISO 13307,
ISO 18593, ISO 707 | IDF 50 and ISO 6887-3). If there is no specific International Standard dealing with the
sampling of the product, the concerned parties should come to an agreement on this subject.
Prepare the initial suspension in accordance with the relevant part of the ISO 6887 series. The
laboratory procedure should start with sample preparation including the enrichment or concentration of
microorganisms and associated genetic markers from the test portion.
Any sample along the food chain is suitable as a test portion, provided it is possible to retrieve nucleic acid
(DNA or RNA, or both) from the test portion if it is present and provided it has been established that the
nucleic acid solution prepared from the test portion does not significantly inhibit the LAMP assay (either
amplification or detection). Appropriate controls shall be included (see 5.3).
Sample preparation is followed by nucleic acid extraction. Microbial cells in the test portion or enriched
culture are lysed to release their nucleic acid (DNA or RNA, or both). If required, a separation stage is
included prior to lysis or a purification step is carried out following lysis, or both.
LAMP amplification of the target nucleic acid sequence shall be performed using specific primers with the
addition of colorimetric substrates, fluorescent dyes or other chemistries, under isothermal conditions in a
suitable instrument. The detection of LAMP amplicon is achieved through real-time monitoring and/or end-
point evaluation of the signal (colour, fluorescence, bioluminescence, turbidity, etc.) in an optical detection
system or end-point detection (e.g. lateral flow, gel electrophoresis). See Annex A.
NOTE More details on the laboratory procedure are given in Clause 8.
4.3 Data interpretation
Amplification through LAMP should be assessed by the respective reporting system (colour changes,
fluorescence plots, bioluminescence curves, turbidity changes, etc.) to indicate if specific amplification of
the target nucleic acid sequence has taken place. Proper controls are incorporated to ensure data validity.
NOTE More details on the data interpretation are given in Clause 9.
4.4 Performance criteria
Criteria including sensitivity, specificity and robustness can be used to evaluate LAMP performance.
NOTE More details on the performance characteristics are given in Clause 10.
5 General laboratory guidance
5.1 General
ISO 22174:2024, Clause 9 and 12.2.2 s
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