Event-specific method for the quantification of event EH92-527-1 potato using real-time PCR : validation report

The JRC as Community Reference Laboratory (CRL) for the GM Food and Feed (see Regulation EC 1829/2003), in collaboration with the European Network of GMO Laboratories (ENGL), has carried out a collaborative study to assess the performance of a quantitative event-specific method to detect and quantify the EH92-527-1 potato transformation event in potato DNA (unique identifier BPS-25271-9). The collaborative trial was conducted according to internationally accepted guidelines. BASF Plant Science GmbH provided the method-specific samples (genomic DNA from 100% EH92-527- 1 freeze-dried potato tubers ), and genomic DNA extracted from fresh potato tubers of the non-GM potato line Prevalent), GeneScan Analytics GmbH provided the report of method optimisation, whereas the JRC prepared the validation samples (calibration samples and blind samples at unknown GM percentage). The trial involved twelve laboratories from ten countries of the European Union. The results of the collaborative trial met ENGL's performance requirements and the scientific understanding about satisfactory method performance. Therefore, the JRC as Community Reference Laboratory considers the method validated as fit for the purpose of regulatory compliance. Considerations are reported regarding the UGPase reference system. The results of the collaborative study are publicly available under http://gmo-crl.jrc.it/. The method may also be submitted to ISO for consideration as international standard.