BS EN ISO 15216-2:2019

What is ISO 15216‑2-Detection of hepatitis A virus and norovirus using real-time RT-PCR about?

ISO 15216 discusses the microbiology of the food chain. ISO 15216‑2 is an international standard on detection of hepatitis A virus and norovirus in foodstuffs ensuring prevention from severe health issues.

ISO 15216‑2 is the second part of a multi-part series that specifies a method for detection of hepatitis A virus (HAV) and norovirus genogroups I (GI) and II (GII), from test samples of foodstuffs or surfaces using real-time RT-PCR.

Note: The method specified under ISO 15216‑2 is not validated for the detection of the target viruses in other foodstuffs (including multicomponent foodstuffs), or any other matrices, nor the detection of other viruses in foodstuffs, surfaces, or other matrices.

Who is ISO 15216‑2- Detection of hepatitis A virus and norovirus using real-time RT-PCR for?

ISO 15216‑2 on the detection of hepatitis, A virus and norovirus using real-time RT-PCR is useful for:

• Food laboratories
• Food scientists
• Food technologists
• Food health and safety departments

Why should you use ISO 15216‑2- Detection of hepatitis A virus and norovirus using real-time RT-PCR?

Hepatitis A virus (HAV) and norovirus are important agents of food-borne human viral illness. No routine methods exist for the culture of norovirus, and HAV culture methods are not appropriate for routine application to food matrices. Detection is reliant on molecular methods using the reverse-transcriptase polymerase chain reaction (RT-PCR). As many food matrices contain substances that are inhibitory to RT-PCR, it is necessary to use an extraction method that produces highly clean RNA preparations that are fit for purpose.

ISO 15216‑2 provides you with methods and procedures to determine the hepatitis A virus and norovirus in foodstuffs through virus extraction, RNA extraction, and using real time RT-PCR.

 ISO 15216‑2 assist in the detection of hepatitis, A virus, and norovirus in foodstuffs such as soft fruit, leaf, stem and bulb vegetables, bottled water, bivalve molluscan shellfish (BMS) to ensure the prevention from severe health issues due to consumption of these foodstuffs.

What is changed since the last update?

BS EN ISO 15216‑2:2019 supersedes ISO/TS 15216-2:2013, which is withdrawn. The main changes with respect to the previous edition are:

• A requirement to use a suitable buffer for the dilution of control materials has been added
• The method for generating process control virus RNA for the standard curve has been changed
• Breakpoints with a defined temperature and time parameters in the extraction methods have been added
• The terminology has been changed from amplification efficiency to RT-PCR inhibition
• The addition of extra real-time RT-PCR reactions for sample RNA and negative controls Method characteristics and the results of method validation studies have been added