EN ISO 15216-1:2017

Name: EN ISO 15216-1:2017
Brand: CEN

Superseded

View Superseded by

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 (ISO 15216-1:2017)

Amended by

EN ISO 15216-1:2017/A1:2021

Superseded date

30-04-2021

Published date

29-03-2017

Publisher

Comite Europeen de Normalisation

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Reagents
6 Equipment and consumables
7 Sampling
8 Procedure
9 Interpretation of results
10 Expression of results
11 Precision
12 Test report
Annex A (normative) - Diagram of procedure
Annex B (normative) - Composition and preparation of reagents
        and buffers
Annex C (informative) - Real-time RT-PCR mastermixes and
        cycling parameters
Annex D (informative) - Real-time RT-PCR primers and
        hydrolysis probes for the detection of HAV, norovirus
        GI and GII and mengo virus (process control)
Annex E (informative) - Growth of mengo virus strain MC[0]
        for use as a process control
Annex F (informative) - RNA extraction using the NucliSENS[R]
        system
Annex G (informative) - Generation of dsDNA control stocks
Annex H (informative) - Generation of EC RNA stocks
Annex I (informative) - Typical optical plate layout
Annex J (informative) - Method validation studies and
        performance characteristics
Bibliography

ISO 15216-1:2017 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. Following 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.This method is not validated for 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.

Committee	CEN/TC 463
DevelopmentNote	Supersedes CEN ISO/TS 15216-1. (04/2017)
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 15216-1:2017/A1:2021
Supersedes	CEN ISO/TS 15216-1:2013

Standards	Relationship
ONORM EN ISO 15216-1 : 2017	Identical
DIN EN ISO 15216-1:2017-07	Identical
SN EN ISO 15216-1 : 2017	Identical
DIN EN ISO 15216-1:2015-09 (Draft)	Identical
SS-EN ISO 15216-1 : 2017	Identical
NF EN ISO 15216-1 : 2017	Identical
UNI EN ISO 15216-1 : 2017	Identical
NEN EN ISO 15216-1 : 2017	Identical
UNE-EN ISO 15216-1:2017	Identical
DIN EN ISO 15216-1 E : 2017	Identical
ISO 15216-1:2017	Identical
NS EN ISO 15216-1 : 2017	Identical
PN EN ISO 15216-1 : 2017	Identical
BS EN ISO 15216-1:2017	Identical
I.S. EN ISO 15216-1:2017	Identical

ISO 22174:2005	Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens General requirements and definitions
ISO 7218:2007	Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinations
ISO 20838:2006	Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens Requirements for amplification and detection for qualitative methods
ISO 5725-2:1994	Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
ISO 17468:2016	Microbiology of the food chain — Technical requirements and guidance on establishment or revision of a standardized reference method
ISO 22119:2011	Microbiology of food and animal feeding stuffs Real-time polymerase chain reaction (PCR) for the detection of food-borne pathogens General requirements and definitions