SFS-EN ISO 15216-2:2019:en

Soveltamisala

Suomenkielistä soveltamisalaa ei ole saatavissa.

This document specifies a method for detection of hepatitis A virus (HAV) and norovirus genogroups I (GI) and II (GII), from test samples of foodstuffs [(soft fruit, leaf, stem and bulb vegetables, bottled water, bivalve molluscan shellfish (BMS)] or surfaces using 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, surfaces or other matrices.

Tämän julkaisun valmistelusta Suomessa vastaa SFS Suomen Standardit, puh. 09 149 9331.

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle

4.1 Virus extraction
4.2 RNA extraction
4.3 Real-time RT-PCR
4.4 Control materials
4.5 Test results

5 Reagents

5.1 General
5.2 Reagents used as supplied
5.3 Reagents requiring preparation

6 Equipment and consumables
7 Sampling
8 Procedure

8.1 General laboratory requirements
8.2 Virus extraction
8.3 RNA extraction
8.4 Real-time RT-PCR

9 Interpretation of results

9.1 General
9.2 Construction of process control virus RNA standard curve
9.3 Control for RT-PCR inhibition
9.4 Calculation of extraction efficiency

10 Expression of results
11 Performance characteristics of the method

11.1 Validation study
11.2 Sensitivity
11.3 Specificity
11.4 LOD50

12 Test report

Annex A Diagram of procedure (normative)
Annex B Composition and preparation of reagents and buffers (normative)
Annex C Real-time RT-PCR mastermixes and cycling parameters (informative)
Annex D Real-time RT-PCR primers and hydrolysis probes for the detection of HAV, norovirus GI and GII and mengo virus (process control) (informative)
Annex E Growth of mengo virus strain MC0 for use as a process control (informative)
Annex F RNA extraction using the BioMerieux NucliSens®33 BioMerieux NucliSens® is the trade name of a product supplied by BioMerieux. This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of the product named. Equivalent products may be used if they can be shown to lead to the same results. system (informative)
Annex G Generation of external control RNA (EC RNA) stocks (informative)
Annex H Typical optical plate layout (informative)
Annex I Method validation studies and performance characteristics (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle

4.1 Virus extraction
4.2 RNA extraction
4.3 Real-time RT-PCR
4.4 Control materials
4.5 Test results

5 Reagents

5.1 General
5.2 Reagents used as supplied
5.3 Reagents requiring preparation

6 Equipment and consumables
7 Sampling
8 Procedure

8.1 General laboratory requirements
8.2 Virus extraction
8.3 RNA extraction
8.4 Real-time RT-PCR

9 Interpretation of results

9.1 General
9.2 Construction of process control virus RNA standard curve
9.3 Control for RT-PCR inhibition
9.4 Calculation of extraction efficiency

10 Expression of results
11 Performance characteristics of the method

11.1 Validation study
11.2 Sensitivity
11.3 Specificity
11.4 LOD50

12 Test report

Annex A Diagram of procedure (normative)
Annex B Composition and preparation of reagents and buffers (normative)
Annex C Real-time RT-PCR mastermixes and cycling parameters (informative)
Annex D Real-time RT-PCR primers and hydrolysis probes for the detection of HAV, norovirus GI and GII and mengo virus (process control) (informative)
Annex E Growth of mengo virus strain MC0 for use as a process control (informative)
Annex F RNA extraction using the BioMerieux NucliSens®33 BioMerieux NucliSens® is the trade name of a product supplied by BioMerieux. This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of the product named. Equivalent products may be used if they can be shown to lead to the same results. system (informative)
Annex G Generation of external control RNA (EC RNA) stocks (informative)
Annex H Typical optical plate layout (informative)
Annex I Method validation studies and performance characteristics (informative)

Bibliography

Tuoteryhmä(t)

07.100.30 Elintarvikemikrobiologia »

Sidokset

Velvoittavat viittaukset

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 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
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

Tekninen komitea

CEN/TC 463 Microbiology of the food chain »

Vahvistuspäivä

27.09.2019

Julkaisupäivä

01.10.2019

Painos

1

Sivumäärä

47

Julkaisun kieli

englanti