Guidance document from the European Network of GMO laboratories (ENGL) : Verification of analytical methods for GMO testing when implementing interlaboratory validated methods

Abstract

In the EU, method validation is an essential part of the process that regulates the introduction of new GMOs as food and/or feed into the market. When the inter-laboratory validation study is completed, the method is ready to be implemented in routine testing laboratories. When implementing the new method, the laboratory has to verify that the method can be used for its intended purpose (method verification). The scope of this document is to provide guidance on how to carry out the method verification. Despite the fact that several guidelines on method verification have been published, no specific guidelines are available for GMO detection. The aim of this guidance document is to harmonise the in-house verification of inter-laboratory validated methods for the qualitative and quantitative detection of GMOs, including element-, construct-, and event-specific methods. Considering that the Polymerase Chain Reaction (PCR) is the method of choice in the EU for the identification and quantification of GMOs, this document refers exclusively to real time PCR. However, if novel methods are subsequently developed that fulfill legal requirements, then this document will be amended accordingly.