Single-laboratory validation of a method for detection of Roundup Ready soy in soybeans: application of new strategies for qualitative validation

Considering expansion of genetically modified organisms and the basic principle of consumers’ right to access information about products, legislations of several countries establish a limit for labelling transgenic food. Qualitative tests based on the polymerase chain reaction (PCR) have been recommended. However, validation of qualitative methods is still a critical point in the quality management of food analysis laboratories. A screening method for the detection of Roundup Ready (RR) soy in soybeans by nested PCR was validated by a novel qualitative approach, in a single-laboratory, considering all fundamental parameters for an adequate evaluation of fitness for purpose. Blank samples of soybeans and formulations containing 0.001 to 1% of RR soy were analysed. Agarose gel electrophoresis and fluorimetry techniques were compared in terms of the quantification of extracted DNA. False-positive rate obtained was 0%, with selectivity and reliability rates of 100.0% for both techniques. Sensitivity and relia...