This document describes the performance characteristics and minimum performance criteria which should be taken into account when conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied for the detection of specific DNA sequences present in foods. The protocol was developed for qualitative real-time PCR methods for the detection of DNA sequences derived from genetically modified foodstuffs. It is applicable also for single-laboratory validation of qualitative PCR methods used for analysis of other food materials, e.g. for species detection and identification. The document does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.
Tämän julkaisun valmistelusta Suomessa vastaa SFS Suomen Standardit, puh. 09 149 9331.
EN ISO 21571:2005 Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Nucleic acid extraction (ISO 21571:2005)
EN ISO 24276:2006 Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - General requirements and definitions (ISO 24276:2006)
ISO 16577:2016 Molecular biomarker analysis -- Terms and definitions
EN ISO 21571:2005 Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Nucleic acid extraction (ISO 21571:2005)
EN ISO 24276:2006 Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - General requirements and definitions (ISO 24276:2006)
ISO 16577:2016 Molecular biomarker analysis -- Terms and definitions
882/2004 Rehu- ja elintarvikelainsäädännön sekä eläinten terveyttä ja hyvinvointia koskevien sääntöjen mukaisuuden varmistamiseksi suoritetusta virallisesta valvonnasta