Overview
CEN ISO/TS 18867:2015 - "Microbiology of the food chain - PCR for the detection of food‑borne pathogens - Detection of pathogenic Yersinia enterocolitica and Yersinia pseudotuberculosis" - specifies real‑time PCR–based, horizontal methods for detecting pathogenic bioserotypes of Y. enterocolitica (two methods) and Y. pseudotuberculosis (one method). The Technical Specification covers detection from enrichment cultures and supports subsequent isolation of colonies. It applies to products for human consumption, animal feeding stuffs and environmental samples, and was issued for provisional application by CEN/ISO.
Key topics and technical requirements
- Real‑time PCR assays: Protocols for amplification and probe‑based detection of pathogenic Yersinia spp., including options for multiplex detection.
- Enrichment procedures: Guidance on microbial enrichment prior to nucleic acid extraction to improve sensitivity for low‑level contamination.
- Nucleic acid extraction: Requirements for extracting bacterial DNA from enriched samples and sample preparations.
- Isolation workflow: Steps that allow recovery and isolation of colonies after PCR screening, enabling culture confirmation.
- Controls and interpretation: Inclusion of positive, negative and process controls; interpretation criteria for PCR results and confirmation pathways.
- Reagents and equipment: Lists of required culture media, selective plates, extraction reagents and real‑time PCR instrumentation categories.
- Annexes with procedures: Informative annexes provide detailed real‑time PCR methods for Y. enterocolitica, detection/isolation of Y. pseudotuberculosis, and multiplex approaches.
- Scope nuance: The assay targeting the ail gene will also detect Y. pestis (shares a variant of the ail gene), though Y. pestis is not normally food‑associated.
- Regulatory status: Issued as a CEN ISO/TS (provisional Technical Specification) and intended for national adoption; conversion to a full European Standard may follow review.
Applications and users
- Food testing laboratories performing routine surveillance and product release testing for Yersinia contamination.
- Public health and clinical labs investigating food‑borne outbreaks involving Yersinia spp.
- Food producers and QA teams implementing HACCP and supplier verification programs.
- Regulatory agencies needing harmonized, horizontal PCR methods for enforcement and monitoring.
- Method developers and validation bodies using the TS as a reference for developing, validating or comparing in‑house assays.
Related standards (context)
- Part of the ISO/CEN family of food microbiology and horizontal methods governed by ISO/TC 34 and CEN/TC 275. Laboratories should use CEN ISO/TS 18867:2015 alongside other ISO/CEN standards for sampling, method validation, and microbiological best practices.
Keywords: CEN ISO/TS 18867:2015, PCR, real‑time PCR, Yersinia enterocolitica, Yersinia pseudotuberculosis, food microbiology, food‑borne pathogens, enrichment, isolation, food safety.