Validation of real-time PCR for the quantification of genetically modifiedsoybeans

According to the preface of the regulation (EC No. 1139/98) labelling due t o minor contamination would not be necessary, if tolerable limits for genet ically modified DNA and protein can be established. For this purpose, metho ds that quantify genetically modified DNA in food based on real time PCR ha ve been described. For the assessment of the results obtained by quantitati ve PCR methods, validation data concerning sensitivity, precision and truen ess are necessary. By means of a published method for the quantification of genetically modified Roundup Ready (TM) soybeans a practical approach to a chieve these validation data is presented in this paper. The data are obtai ned under repeatability conditions with series of DNA preparations and dilu tions. By the use of this approach, the confidence interval and limits of q uantification and detection can be specified for each sample.