ISO 20838-2006 PDF

Full title and description

Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the detection of food-borne pathogens — Requirements for amplification and detection for qualitative methods (ISO 20838:2006). This International Standard gave a framework of requirements and minimal performance characteristics for qualitative PCR amplification and detection aimed at ensuring comparable and reproducible results between laboratories.

Abstract

ISO 20838:2006 provided general requirements for the specific amplification of target nucleic acid sequences and for the detection and confirmation of the identity of amplified products for qualitative PCR methods used to detect food‑borne pathogens. The standard described guidelines, minimum requirements and performance characteristics intended to produce comparable and reproducible laboratory results and was applicable primarily to food and feed matrices (and adaptable to other matrices such as environmental samples).

General information

• Status: Withdrawn (International Standard withdrawn and replaced by a more recent document).
• Publication date: April 2006 (2006-04).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 07.100.30 — Food microbiology.
• Edition / version: Edition 1 (2006).
• Number of pages: 7 pages (published edition).

Scope

ISO 20838:2006 set out requirements for amplification and detection steps in qualitative PCR methods for detecting food‑borne pathogens. It addressed criteria for specific amplification of target sequences, detection and confirmation of amplified nucleic acid identity, and minimum performance characteristics to ensure comparability and reproducibility across laboratories. The standard was developed for pathogens in food and feed matrices but could be applied, with adaptation, to other matrices such as environmental samples.

Key topics and requirements

• Framework for qualitative PCR workflows (amplification and detection) aimed at food‑borne pathogen identification.
• Requirements for specific amplification of target nucleic acids and measures to avoid false positives/negatives.
• Detection and confirmation procedures for amplified products (identity confirmation).
• Minimum performance characteristics and guidelines to achieve reproducible inter‑laboratory results.
• Applicability notes for food, feed and environmental matrices and relationship to sample‑preparation guidance (see related standards).
• Reference to validation and method verification protocols that laboratories should follow when implementing alternative or in‑house PCR methods.

Typical use and users

Used by food and feed testing laboratories, public health and regulatory laboratories, method developers and quality managers involved in microbiological testing of food‑chain samples. Typical uses included establishing method requirements for qualitative PCR assays, setting internal laboratory procedures for amplification/detection steps, and helping align laboratory practice with international expectations for reproducibility.

Related standards

Key related documents include ISO 22174 (general requirements and definitions for PCR in the food chain; the 2024 revision supersedes earlier documents), ISO 20837 (requirements for sample preparation for qualitative PCR detection), and ISO 16140 (protocols for validation of alternative methods). These documents together provide the broader framework for PCR method validation, sample preparation and general PCR definitions in food microbiology.

Keywords

PCR, polymerase chain reaction, qualitative detection, food‑borne pathogens, amplification, detection, nucleic acid, food microbiology, method requirements, reproducibility, ISO 20838.

FAQ

Q: What is this standard?

A: ISO 20838:2006 was an ISO International Standard that specified requirements for amplification and detection steps in qualitative PCR methods for the detection of food‑borne pathogens.

Q: What does it cover?

A: It covered general requirements for specific amplification of target nucleic acid sequences, detection and confirmation of amplified product identity, and minimum performance characteristics and guidelines to promote comparable and reproducible qualitative PCR results across laboratories.

Q: Who typically uses it?

A: Food and feed testing laboratories, public health/regulatory labs, method developers, accreditation bodies and quality managers involved in microbiological testing of food‑chain samples and in implementing or validating qualitative PCR assays.

Q: Is it current or superseded?

A: ISO 20838:2006 has been withdrawn and superseded by updated guidance in ISO 22174 (the 2024 edition is the current general PCR document for the food chain). Laboratories should consult ISO 22174:2024 and related, current ISO documents for up‑to‑date requirements.

Q: Is it part of a series?

A: Yes — it formed part of the set of ISO documents on PCR and microbiological methods for the food chain (for example ISO 22174 for general PCR requirements, ISO 20837 for sample preparation, and ISO 16140 for validation of alternative methods). These standards are coordinated by ISO/TC 34/SC 9.

Q: What are the key keywords?

A: PCR, qualitative detection, food‑borne pathogen, amplification, detection, validation, sample preparation, food microbiology, ISO 20838.