BS EN ISO 15216-1:2017+A1:2021

What is ISO 15216‑1 about?  

ISO 15216‑1 is the first part of the ISO 15216 multi-series that focuses on the microbiology of the food chain. ISO 15216‑1  specifies a method for the quantification of levels of HAV and norovirus genogroup I (GI) and II (GII) RNA, from test samples of foodstuffs (soft fruit, leaf, stem and bulb vegetables, bottled water, BMS) or food surfaces. 

The method used in ISO 15216‑1 follows the liberation of viruses from the test sample, viral RNA is then extracted by lysis with guanidine thiocyanate and adsorption on silica. Target sequences within the viral RNA are amplified and detected by real-time RT-PCR. 

Note: The method used in ISO 15216‑1 is not validated for the detection of the target viruses in other foodstuffs (including multi-component foodstuffs), or any other matrices, nor for the detection of other viruses in foodstuffs, food surfaces or other matrices. 

Who is ISO 15216‑1 for? 

ISO 15216‑1  on determination of viruses in the microbiology food chain is useful for: 

• Microbiologists 
• Virologists 
• Virology laboratories 

Why should you use ISO 15216‑1?  

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 therefore reliant on molecular methods using the reverse- transcriptase-polymerase chain reaction (RT-PCR). 

ISO 15216‑1  specifies a method for the quantification of levels of HAV and norovirus RNA, from test samples of foodstuffs, or food surfaces. 

ISO 15216‑1 enables you to detect bacteria in foods in combination with cultural enrichment steps and for the direct detection of bacteria and viruses in food samples without enrichment. 

What’s changed since the last update?  

BS EN ISO 15216‑1:2017+A1:2021 supersedes ISO/TS 15216‑1:2013. BS EN ISO 15216‑1:2017+A1:2021 includes some technical changes with respect to ISO/TS 15216‑1:2013. These include: 

• Use of linear dsDNA molecules for quantification, use of suitable buffer for dilution of control materials prescribed 
• Change to the method for generating process control virus RNA for the standard curve, and change in terminology from amplification efficiency to RT-PCR inhibition 
• Addition of breakpoints with defined temperature and time parameters in the extraction methods, the addition of extra real-time RT-PCR reactions for negative controls, the addition of precision data and results of an interlaboratory study