Guidelines for validation of qualitative real-time PCR methods

As for many areas of molecular testing, detection of Genetically Modified Organisms (GMO) relies on the real-time Polymerase Chain Reaction (qPCR) technology. Due to the increasing number of GMO, a screening approach using qualitative screening methods has become an integrated part of GMO detection. However, specific guidelines for the validation of these methods are lacking. Here, a pragmatic approach to conduct in-house and inter-laboratory validation studies for GMO screening methods, is proposed. Such guidelines could be adapted to other areas where qualitative qPCR methods are used for molecular testing allowing to implement easily a more reliable screening phase where necessary.

BROEDERS Sylvia;  HUBER Ingrid;  GROHMANN Lutz;  BERBEN Gilbert;  TAVERNIERS Isabel;  MAZZARA Marco;  ROOSENS Nancy;  MORISSET Dany; 

2015-01-13

ELSEVIER SCIENCE LONDON

JRC93345

0924-2244,   

http://www.sciencedirect.com/science/article/pii/S0924224414000661,    https://publications.jrc.ec.europa.eu/repository/handle/JRC93345,   

10.1016/j.tifs.2014.03.008,