Single and multi-laboratory validation of a droplet digital PCR method

The European Union Reference Laboratory for GM Food and Feed (EURL GMFF) defined together with the European Network of GMO Laboratories (ENGL) the performance criteria for the analytical methods (ENGL, 2015). In particular, the fitness for purpose of their accuracy, in terms of trueness and precision, has to be confirmed by multi-laboratory validation studies organised according to international standards. Until now, a significant number of real-time PCR based methods have been successfully developed and validated according to those criteria. In recent years, digital PCR (dPCR) has emerged as a new analytical principle in various fields that require quantification of nucleic acid target sequences, including GMO control. However, the assessment of a dPCR method for GMO analysis through a collaborative validation study has not been described so far. Moreover, dPCR may need the conversion of the measurement results expressed in a copy number ratio into the mass fraction of the GMO, e.g. if the data would be used for the enforcement of the official EU control legislation (Corbisier et al., 2017; Corbisier & Emons, 2019). This study was aiming to demonstrate that the performance criteria set by EU and other international standards are achievable with dPCR methods, allowing their application by official control laboratories for the control of the GMO market.

GATTO Francesco;  SAVINI Cristian;  SACCO Maria-Grazia;  VINCIGUERRA Daniela;  BUTTINGER Gerhard;  CORBISIER Philippe;  MAZZARA Marco;  EMONS Hendrik; 

2023-05-19

ELSEVIER SCI LTD

JRC128706

0956-7135 (online),   

https://www.sciencedirect.com/science/article/pii/S0956713522003103,    https://publications.jrc.ec.europa.eu/repository/handle/JRC128706,   

10.1016/j.foodcont.2022.109117 (online),