ISO 15216-2-2019 PDF

Full title and description

Microbiology of the food chain — Horizontal method for determination of hepatitis A virus and norovirus using real‑time RT‑PCR — Part 2: Method for detection. This International Standard specifies a standardized laboratory procedure for detecting hepatitis A virus (HAV) and human norovirus genogroups I (GI) and II (GII) in certain foodstuffs and on surfaces using real‑time reverse transcription PCR (real‑time RT‑PCR).

Abstract

This document specifies a method for detection of hepatitis A virus (HAV) and norovirus genogroups I (GI) and II (GII) from test samples of specified foodstuffs (soft fruit, leaf/stem/bulb vegetables, bottled water and bivalve molluscan shellfish) and from surfaces using real‑time RT‑PCR. The method is validated only for the listed matrices and is not validated for other foodstuffs (including multi‑component foods), other matrices or for detection of other viruses.

General information

• Status: Published (International Standard; confirmed following systematic review).
• Publication date: 23 July 2019 (edition 1:2019).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 07.100.30 (Food microbiology).
• Edition / version: Edition 1 (2019).
• Number of pages: 40 pages (official ISO publication information).

Details above are taken from the ISO bibliographic record for ISO 15216-2:2019; the standard was last reviewed and confirmed in 2024, so this version remains current.

Scope

The standard defines a horizontal qualitative detection method for HAV and norovirus GI/GII in validated matrices (soft fruit; leaf, stem and bulb vegetables; bottled water; bivalve molluscan shellfish) and on surfaces. It covers sample preparation (release/concentration of virus where applicable), RNA extraction, and detection by one‑step real‑time RT‑PCR, together with recommended controls and interpretation criteria. It explicitly excludes application to other food matrices, multi‑component foods or the detection of other viruses unless appropriately validated.

Key topics and requirements

• Target organisms: hepatitis A virus (HAV) and human norovirus genogroups I (GI) and II (GII).
• Methodology: one‑step real‑time RT‑PCR following sample processing and RNA extraction; includes criteria for valid amplification and result interpretation.
• Validated sample matrices: soft fruit; leaf, stem and bulb vegetables; bottled water; bivalve molluscan shellfish (BMS); and surfaces.
• Quality controls: use of a process control virus and internal/amplification controls to monitor extraction efficiency and inhibition is recommended (choice of process control — e.g., mengovirus, murine norovirus or MS2 phage — depends on laboratory practice and matrix); laboratories should follow the standard’s guidance on controls and recovery calculation.
• Limitations: not validated for multi‑component foods, other matrices or for detection of non‑target viruses without additional validation.

Typical use and users

Used by food microbiology laboratories, public health reference laboratories, regulatory bodies, food producers and testing service providers for screening and surveillance of HAV and norovirus contamination in the validated food matrices and on surfaces. It supports outbreak investigations, routine monitoring, and verification of hygiene controls where molecular viral detection is required.

Related standards

ISO 15216 is a multi‑part series. The most directly related document is ISO 15216‑1:2017 (Part 1: Method for quantification), which provides the quantitative method and has an amendment (ISO 15216‑1:2017/Amd 1:2021). The earlier Technical Specification ISO/TS 15216‑2:2013 was withdrawn and replaced by ISO 15216‑2:2019. Laboratories often use Parts 1 and 2 together when both qualitative detection and quantification are needed.

Keywords

food virology; hepatitis A virus; norovirus; real‑time RT‑PCR; food microbiology; process control virus; viral extraction; bivalve molluscan shellfish; soft fruit; vegetables; surfaces.

FAQ

Q: What is this standard?

A: ISO 15216‑2:2019 is an International Standard specifying a horizontal laboratory method for qualitative detection of hepatitis A virus and norovirus (GI and GII) in certain food matrices and on surfaces using real‑time RT‑PCR.

Q: What does it cover?

A: It covers sample handling for validated matrices, RNA extraction and one‑step real‑time RT‑PCR detection, plus recommendations for controls, result validation and interpretation. It does not cover matrices or viruses that have not been validated without additional verification.

Q: Who typically uses it?

A: Food testing laboratories, public health/reference labs, regulators and commercial testing providers involved in food safety surveillance, outbreak response and verification of sanitation or supply‑chain controls.

Q: Is it current or superseded?

A: ISO 15216‑2:2019 is the current published version of Part 2; the ISO record shows it was published in July 2019 and was reviewed and confirmed in 2024, so it remains current as published. The earlier ISO/TS 15216‑2:2013 was withdrawn and replaced by this 2019 edition.

Q: Is it part of a series?

A: Yes — ISO 15216 is a series. Part 1 (ISO 15216‑1:2017) specifies the quantitative method; Part 2 (this standard) specifies the qualitative detection method. Part 1 has an amendment published in 2021. Laboratories commonly reference both parts depending on whether detection or quantification is required.

Q: What are the key keywords?

A: Hepatitis A virus (HAV); Norovirus GI/GII; food virology; real‑time RT‑PCR; process control; RNA extraction; soft fruit; vegetables; bivalve molluscan shellfish; surfaces.