ISO 19020-2017 PDF

Full title and description

ISO 19020:2017 — Microbiology of the food chain — Horizontal method for the immunoenzymatic detection of staphylococcal enterotoxins in foodstuffs. This International Standard specifies a two‑step screening procedure (extraction and dialysis‑based concentration, followed by immunoenzymatic detection using commercially available kits) for the detection of staphylococcal enterotoxins SEA, SEB, SECs, SED and SEE in foods intended for human consumption.

Abstract

ISO 19020:2017 defines a horizontal screening method to detect heat‑stable staphylococcal enterotoxins (types SEA–SEE) in a wide range of food matrices. The method comprises (a) extraction from a representative test portion and concentration based on a dialysis principle, and (b) immunoenzymatic (EIA/ELISA) detection using commercial kits that meet the standard’s performance criteria (sensitivity, specificity, LOD50). The standard is the result of international validation work and has been adopted as a reference/enacted method in relevant regulatory and reference laboratory contexts.

General information

• Status: Published (International Standard, confirmed).
• Publication date: June 2017 (2017‑06 / published June 2017).
• Publisher: International Organization for Standardization (ISO), developed in cooperation with CEN/TC 275 under the Vienna Agreement.
• ICS / categories: 07.100.30 — Food microbiology.
• Edition / version: Edition 1 (2017).
• Number of pages: 22 pages (approx.).

Key administrative/technical committee: ISO/TC 34/SC 9 (Microbiology).

Scope

ISO 19020:2017 is applicable to the screening of staphylococcal enterotoxins types SEA, SEB, SEC (all SEC variants), SED and SEE in foodstuffs. The standard describes sample preparation, a dialysis‑based concentration step to improve sensitivity, and use of immunoenzymatic detection kits that meet defined performance criteria. Other enterotoxin types (for example SEG, SEH, SEI, SER, SES, SET and newer types) are acknowledged but are only covered when appropriate commercial detection kits exist and validation has been carried out to demonstrate conformity with the method’s performance requirements. The method is suitable for routine screening, outbreak investigation and regulatory monitoring across a variety of matrices (ready‑to‑eat foods, meat products, dairy, desserts, fish, etc.).

Key topics and requirements

• Two‑step workflow: extraction of toxin from test portion followed by dialysis concentration (to increase assay sensitivity) and subsequent immunoenzymatic assay (EIA/ELISA) for detection.
• Performance criteria for kits: specified minimum requirements for sensitivity, specificity and LOD50; only kits meeting these criteria are considered suitable for use with the method.
• Matrix coverage and validation: interlaboratory validation across representative food matrices; instructions for adapting test portion sizes and processing for different foods.
• Equipment and consumables guidance: recommendations for centrifugation, dialysis membranes (MWCO), reagents, controls and quality‑assurance measures to ensure consistent screening results.
• Result interpretation and reporting: principles for expressing screening outcomes, handling presumptive positive samples (confirmation and follow‑up), and recommended documentation for traceability.
• Regulatory recognition: the method has been adopted/recognized in EU reference contexts and supports compliance with microbiological criteria and regulatory monitoring requirements.

Typical use and users

Primary users are food microbiology laboratories, national and regional public health and food safety reference laboratories, regulatory agencies, food manufacturers’ quality control teams, third‑party testing providers and research groups developing or validating detection kits. Typical applications include routine screening for staphylococcal enterotoxins in finished products, support for outbreak investigations, verification testing under food safety programs, and performance evaluation of commercial immunoenzymatic kits.

Related standards

Relevant and commonly referenced standards and documents include ISO 7218 (general laboratory requirements for microbiology of food and animal feeding stuffs), ISO 16140 series (method validation and verification for microbiological methods), ISO 3696 (water for analytical laboratory use) and broader food safety/regulatory documents such as EU Commission Regulation (EC) No 2073/2005 and its later amendments which address microbiological criteria for foods. The standard was published as EN ISO 19020 in the CEN/ISO cooperation context and is associated with performance and validation guidance in the scientific literature.

Keywords

staphylococcal enterotoxins, SEA, SEB, SEC, SED, SEE, immunoenzymatic assay, EIA, ELISA, dialysis concentration, food microbiology, screening method, method validation, ISO 19020:2017, food safety, toxin detection.

FAQ

Q: What is this standard?

A: ISO 19020:2017 is an international standard that specifies a horizontal screening method for the immunoenzymatic detection of staphylococcal enterotoxins (types SEA–SEE) in foodstuffs, combining an extraction/concentration step with commercial EIA kits.

Q: What does it cover?

A: It covers sample preparation (extraction), a dialysis‑based concentration procedure to improve assay sensitivity, guidance on using commercial immunoenzymatic detection kits that meet defined performance criteria (sensitivity, specificity, LOD50), validation requirements and matrix considerations for foods intended for human consumption.

Q: Who typically uses it?

A: Food testing and public health laboratories, regulatory authorities, food industry QC labs, third‑party testing providers, reference laboratories and researchers involved in assay development or method validation.

Q: Is it current or superseded?

A: ISO 19020:2017 is the published edition (2017). As with all ISO standards it is subject to periodic review (typically every 5 years); users should check the issuing body for any confirmation, amendments or revisions since publication.

Q: Is it part of a series?

A: It sits within the ISO "Microbiology of the food chain" sector and is closely associated with method validation and laboratory practice standards (for example ISO 16140 series and ISO 7218). It was developed in cooperation between ISO/TC 34/SC 9 and CEN/TC 275 (EN ISO form).

Q: What are the key keywords?

A: Staphylococcal enterotoxins, SEA–SEE, ELISA/EIA, dialysis concentration, food microbiology, screening method, method validation, ISO 19020.