DIN CEN/TS 16707 DIN SPEC 10707:2014-12

Largely, detection of materials derived from genetically modified organisms (GMOs) in a given sample employ polymerase chain reaction (PCR) analysis, specifically real-time PCR. A general strategy for GMO detection and identification by means of PCR analysis and a stepwise approach is described. In initial screening analysis, DNA sequences of genetic elements common to many GMOs are targeted. According to its purpose, screening is a test to rapidly and reliably sort samples into groups. Once the samples are grouped, screening facilitates and potentially reduces subsequent analytical work and results interpretation. The screening strategy should be adjusted to the scope (food, feed or seed, crop-specific etc.) of the test(s). This document takes the general principle of GMO detection strategies as a basis and describes the underlying analytical steps for complex screening (known as the matrix-approach [1]). The document is written primarily for screening strategies applying real-time PCR methods. Other PCR methodologies may be applicable in the same way. The terms 'screening method' and 'screening strategies' are not interchangeable and have different meanings in this document. This Technical Specification describes strategies for the detection of genetically modified (GM) DNA in food products by means of PCR methods. It has been established for food matrices, but could also be applied to other matrices (e. g. feed and plant samples from the environment). PCR detection of GM DNA is based on targeting segments of transgenic DNA sequences genetic elements, constructs or insertion sites of transgenes). For effective analysis of a sample for the presence of DNA derived from GM material this document refers to an approach using combinations of detection methods simultaneously or hierarchically in subsequent reactions. The analysis is based on the so called 'matrix approach' as a general strategy. Examples for the implementation and application of this approach are described. The document also provides guidelines for the validation of the performance criteria of PCR methods applied in screening approaches in order to assure reliable results