SIST EN ISO 15216-1:2017/A1:2021 PDF

Overview

SIST EN ISO 15216-1:2017/A1:2021 is an important international standard titled Microbiology of the food chain - Horizontal method for determination of hepatitis A virus and norovirus using real-time RT-PCR - Part 1: Method for quantification - Amendment 1. Published by the European Committee for Standardization (CEN), this amendment updates the original 2017 standard and provides detailed guidance on the quantification of hepatitis A virus and noroviruses in food products and related matrices.

This standard applies molecular detection techniques based on real-time reverse transcription polymerase chain reaction (real-time RT-PCR), establishing reliable and reproducible methods to quantify viral contamination with high specificity and sensitivity. It is essential for food safety laboratories, public health authorities, and food manufacturers concerned with viral contamination control along the food chain.

Key Topics

• Horizontal Methodology: Provides a standardized, horizontal approach applicable across a wide range of food matrices and environmental samples.
• Real-Time RT-PCR Technique: Specifies the use of real-time reverse transcription PCR for viral RNA quantification, enabling rapid and accurate detection of hepatitis A virus and norovirus.
• Sample Preparation and Extraction: Describes detailed protocols for sample processing, including viral RNA extraction using magnetic silica technology, with modifications introduced in the 2021 amendment.
• Reagents and Buffers: Updates on reagents such as EDTA disodium dihydrate, concentration specifics, and preparation instructions to ensure consistency and reliability.
• Quality Control and Validation: Sets performance criteria for assay efficiency, sensitivity, and specificity aligned with microbiological safety standards.
• Automated and Manual Procedures: Accommodates both manual and automated RNA extraction systems to facilitate laboratory workflows and scalability.

Applications

• Food Safety Testing: Critical for testing fresh produce, shellfish, bottled water, and ready-to-eat foods to detect viral pathogens that impact public health.
• Epidemiological Surveillance: Supports monitoring and outbreak investigations by reliably quantifying viral load in contaminated food and environmental samples.
• Regulatory Compliance: Helps laboratories meet national and international food safety regulations by adhering to a harmonized, validated molecular method.
• Research and Development: Facilitates viral contamination studies and the development of improved food processing interventions targeting viral elimination.
• Quality Assurance Programs: Integrates into routine monitoring schemes within food processing facilities and water quality assessments.

Related Standards

• ISO 15216-2:2013 - Microbiology of the food chain - Horizontal method for determination of hepatitis A virus and norovirus using real-time RT-PCR - Part 2: Method for qualitative detection Complements Part 1 by providing the qualitative detection protocol for the same viruses.

• ISO/TS 15216 series - Technical specifications dealing with procedure validation and performance characteristics of viral detection in food.

• ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories, applicable for laboratories implementing these methods.

• CEN/TC 463 Standards - Other European standards for microbiology of the food chain that align with viral detection and quantification methods.

SIST EN ISO 15216-1:2017/A1:2021 represents a critical evolution in the standardization of viral detection within the food microbiology sector. Its focus on the quantitative real-time RT-PCR method provides practical benefits in enhancing food safety surveillance, outbreak response, and regulatory adherence. Adoption of this amendment ensures robust, consistent testing practices in food virology, safeguarding public health across the global food supply chain.