caa a22 4500 605466173 CHVBK 20210128100306.0 cr unu---uuuuu 210128e20150401xx s 000 0 eng 10.1007/s00769-015-1108-5 doi (NATIONALLICENCE)springer-10.1007/s00769-015-1108-5 Collaborative trial validation of cry1Ab/Ac and Pubi-cry TaqMan-based real-time PCR assays for detection of DNA derived from genetically modified Bt plant products [Elektronische Daten] [Lutz Grohmann, Ralf Reiting, Dietrich Mäde, Steffen Uhlig, Kirsten Simon, Kirstin Frost, Gurinder Randhawa, Katrin Zur] Presence of genetic modifications in rice products originating from China and imported to the European Union market is detected since 2006. Neither these products from China nor any other genetically modified rice lines are approved as food or feed in the EU. The transgenic rice varieties identified contain genetic elements and constructs coding for insect-resistance genes from Bacillus thuringiensis (Bt) coding for insecticidal crystal (cry) proteins. In particular, DNA sequences coding for codon-optimised or fused cry1Ab/c genes and constructs driven by the maize ubiquitin promoter (P-ubiZM1) were identified. For improved screening and identification of genetic modifications present in Asian rice products, two TaqMan-based real-time PCR assays targeting codon-optimised cry1Ab/Ac and the Pubi-cry construct have been developed. These assays have been validated in an international collaborative trial with 17 participants from 10 countries. Based on a new mathematical-statistical model and an adjusted experimental set-up of the collaborative trial, a close examination of the limit of detection (LOD 95%) and the probability of detection of the qualitative PCR assays was conducted. The evaluation of the method performance characteristics and results of the collaborative trial validation are presented. Springer-Verlag Berlin Heidelberg, 2015 Genetically modified organism (GMO) nationallicence Cry1Ab nationallicence Maize ubiquitin promoter (P-ubiZM1) nationallicence Rice nationallicence Detection method nationallicence Real-time PCR nationallicence Probability of detection (POD) nationallicence Collaborative trial study nationallicence Grohmann Lutz Federal Office of Consumer Protection and Food Safety, Mauerstr. 39-42, 10117, Berlin, Germany aut Reiting Ralf Hessian State Laboratory, Druseltalstr.67, 34131, Kassel, Germany aut Mäde Dietrich State Office for Consumer Protection, Freiimfelder Str. 68, 06112, Halle (Saale), Germany aut Uhlig Steffen QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut Simon Kirsten QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut Frost Kirstin QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut Randhawa Gurinder Genomic Resources Division, National Bureau of Plant Genetic Resources, Pusa Campus, 110012, New Delhi, India aut Zur Katrin Federal Office of Consumer Protection and Food Safety, Mauerstr. 39-42, 10117, Berlin, Germany aut Accreditation and Quality Assurance Springer Berlin Heidelberg 20/2(2015-04-01), 85-96 0949-1775 20:2<85 2015 20 769 https://doi.org/10.1007/s00769-015-1108-5 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s00769-015-1108-5 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Grohmann Lutz Federal Office of Consumer Protection and Food Safety, Mauerstr. 39-42, 10117, Berlin, Germany aut NATIONALLICENCE 700 1- Reiting Ralf Hessian State Laboratory, Druseltalstr.67, 34131, Kassel, Germany aut NATIONALLICENCE 700 1- Mäde Dietrich State Office for Consumer Protection, Freiimfelder Str. 68, 06112, Halle (Saale), Germany aut NATIONALLICENCE 700 1- Uhlig Steffen QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut NATIONALLICENCE 700 1- Simon Kirsten QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut NATIONALLICENCE 700 1- Frost Kirstin QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut NATIONALLICENCE 700 1- Randhawa Gurinder Genomic Resources Division, National Bureau of Plant Genetic Resources, Pusa Campus, 110012, New Delhi, India aut NATIONALLICENCE 700 1- Zur Katrin Federal Office of Consumer Protection and Food Safety, Mauerstr. 39-42, 10117, Berlin, Germany aut NATIONALLICENCE 773 0- Accreditation and Quality Assurance Springer Berlin Heidelberg 20/2(2015-04-01), 85-96 0949-1775 20:2<85 2015 20 769