Overview
ISO 15216-1:2017/Amd 1:2021 is an internationally recognized amendment to the ISO 15216-1:2017 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." Published by ISO in March 2021, this amendment refines critical aspects of the quantification method for detecting hepatitis A virus (HAV) and norovirus in the food chain using real-time reverse transcription polymerase chain reaction (RT-PCR).
This standard is essential for laboratories and organizations involved in food safety and public health, providing a harmonized, sensitive, and reliable method for quantifying viral contamination. It enhances the accuracy and reproducibility of hepatitis A and norovirus viral load measurements, which are significant for outbreak investigations and risk assessments related to foodborne viral pathogens.
Key Topics
The amendment includes important updates and clarifications to the original 2017 standard, focusing on:
- Reagent Specifications: Introduction of clarified chemical reagents such as Ethylenediaminetetraacetic acid (EDTA) disodium dihydrate, with precise concentrations and storage requirements to improve assay consistency.
- Sample Processing: Guidance for testing water samples up to 2 liters, ensuring complete testing of the entire volume with volume recording for traceability.
- RNA Extraction Protocols: Detailed procedures for RNA extraction using magnetic silica beads and NucliSens lysis buffer, with updates on incubation, washing, and elution steps that optimize viral RNA recovery.
- Use of Controls: Inclusion of Mengo virus strain MC as a non-pathogenic process control to validate assay performance without biosafety risks.
- Equipment and Automation: Specifications for instrumentation, including magnetic racks and thermoshakers with defined operating parameters to standardize processing conditions. The amendment also recognizes the use of automated RNA extraction platforms compatible with the method.
- Quality and Safety Considerations: Emphasis on correct reagent storage, adherence to incubation times, and avoidance of foaming during washing steps to ensure RNA integrity and assay accuracy.
Applications
ISO 15216-1:2017/Amd 1:2021 is widely applicable in:
- Food Safety Testing: Quantification of hepatitis A virus and norovirus in food products, water, and environmental samples to prevent foodborne viral infections.
- Public Health Surveillance: Providing laboratories with validated methods to monitor viral contamination trends and support epidemiological investigations during outbreak scenarios.
- Regulatory Compliance: Enabling food producers, processors, and regulatory bodies to comply with food safety regulations and standards by implementing consistent viral detection methods.
- Quality Control in Food Production: Assisting the food industry in verifying hygiene and sanitation practices by detecting trace viral contamination throughout the food chain.
- Research and Validation: Facilitating academic and industrial research to develop improved detection technologies and understand viral transmission dynamics in food environments.
Related Standards
ISO 15216-1:2017/Amd 1:2021 is part of a broader framework on viral detection in the food chain, closely related to:
- ISO 15216-2 - Method for qualitative detection of hepatitis A virus and norovirus using real-time RT-PCR.
- Other ISO standards in the ISO/TC 34/SC 9 series addressing microbiological methods in food safety.
- Guidance documents from the European Committee for Standardization (CEN/TC 463), which collaborates with ISO on food microbiology standards.
- Complementary standards on viral detection in water and environmental matrices, often used alongside this method for comprehensive microbial risk assessment.
By adhering to ISO 15216-1:2017/Amd 1:2021, laboratories and industries can ensure robust, accurate, and internationally harmonized quantification of critical foodborne viruses, boosting consumer protection and contributing to global food safety initiatives.
Open preview (PDF)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
