Validation of 13 duplex droplet digital PCR systems for quantitative GMO analysis of most prevalent GMO traits

Digital PCR methods were recently introduced in food analysis. To run these methods within the scope of ISO17025, they have to be validated. Although several guidelines are available, each laboratory has to implement these guidelines in an adapted validation scheme. We present here one possible implementation. We chose 13 GMO traits which were predominantly detected in the past. The results show that in the range of 1% GMO content, the digital PCR has a little superior performance compared to real time PCR. In the range of the detection limit, measurement uncertainty remains comparable to real time PCR. During validation, a conversion factor was determined for each trait suggesting that the calculation from % copies/copies to % weight/weight may be possible. This shows that GMO contents can be measured without the use of reference material by the validation described here and determination of a conversion factor, which is a great improvement in terms of expense and storage capacity.