caa a22 4500 60546619X CHVBK 20210128100306.0 cr unu---uuuuu 210128e20150401xx s 000 0 eng 10.1007/s00769-015-1112-9 doi (NATIONALLICENCE)springer-10.1007/s00769-015-1112-9 Validation of qualitative PCR methods on the basis of mathematical-statistical modelling of the probability of detection [Elektronische Daten] [Steffen Uhlig, Kirstin Frost, Bertrand Colson, Kirsten Simon, Dietrich Mäde, Ralf Reiting, Petra Gowik, Lutz Grohmann] A new model for the probability of detection (POD curve) for qualitative PCR methods examined in a method validation collaborative study is presented. The model allows the calculation of the POD curve and the limit of detection (LOD 95%), i.e. the number of copies of the target DNA sequence required to ensure 95% probability of detection. The between-laboratory variability of the limit of detection is used to derive the between-laboratory reproducibility of the PCR method. The model is closely related to the approach for quantitative methods described in ISO 5725.2:2002, and the relative limit of detection approach described in the new standard ISO 16140-2:2014. Springer-Verlag Berlin Heidelberg, 2015 Probability of detection ( POD ) nationallicence Collaborative study nationallicence Real-time PCR nationallicence Validation nationallicence Generalized linear mixed model (GLMM) nationallicence Complementary log-log model nationallicence Uhlig Steffen QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut Frost Kirstin QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut Colson Bertrand QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut Simon Kirsten QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut Mäde Dietrich State Office for Consumer Protection, Freiimfelder Str. 68, 06112, Halle (Saale), Germany aut Reiting Ralf Hessian State Laboratory, Druseltalstr. 67, 34131, Kassel, Germany aut Gowik Petra Federal Office of Consumer Protection and Food Safety, Mauerstr. 39-42, 10117, Berlin, Germany aut Grohmann Lutz 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), 75-83 0949-1775 20:2<75 2015 20 769 https://doi.org/10.1007/s00769-015-1112-9 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/s00769-015-1112-9 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Uhlig Steffen QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut NATIONALLICENCE 700 1- Frost Kirstin QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut NATIONALLICENCE 700 1- Colson Bertrand QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut NATIONALLICENCE 700 1- Simon Kirsten QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany aut NATIONALLICENCE 700 1- Mäde Dietrich State Office for Consumer Protection, Freiimfelder Str. 68, 06112, Halle (Saale), Germany aut NATIONALLICENCE 700 1- Reiting Ralf Hessian State Laboratory, Druseltalstr. 67, 34131, Kassel, Germany aut NATIONALLICENCE 700 1- Gowik Petra Federal Office of Consumer Protection and Food Safety, Mauerstr. 39-42, 10117, Berlin, Germany aut NATIONALLICENCE 700 1- Grohmann Lutz 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), 75-83 0949-1775 20:2<75 2015 20 769