Validation of qualitative PCR methods on the basis of mathematical-statistical modelling of the probability of detection

Verfasser / Beitragende:
[Steffen Uhlig, Kirstin Frost, Bertrand Colson, Kirsten Simon, Dietrich Mäde, Ralf Reiting, Petra Gowik, Lutz Grohmann]
Ort, Verlag, Jahr:
2015
Enthalten in:
Accreditation and Quality Assurance, 20/2(2015-04-01), 75-83
Format:
Artikel (online)
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024 7 0 |a 10.1007/s00769-015-1112-9  |2 doi 
035 |a (NATIONALLICENCE)springer-10.1007/s00769-015-1112-9 
245 0 0 |a Validation of qualitative PCR methods on the basis of mathematical-statistical modelling of the probability of detection  |h [Elektronische Daten]  |c [Steffen Uhlig, Kirstin Frost, Bertrand Colson, Kirsten Simon, Dietrich Mäde, Ralf Reiting, Petra Gowik, Lutz Grohmann] 
520 3 |a 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. 
540 |a Springer-Verlag Berlin Heidelberg, 2015 
690 7 |a Probability of detection ( POD )  |2 nationallicence 
690 7 |a Collaborative study  |2 nationallicence 
690 7 |a Real-time PCR  |2 nationallicence 
690 7 |a Validation  |2 nationallicence 
690 7 |a Generalized linear mixed model (GLMM)  |2 nationallicence 
690 7 |a Complementary log-log model  |2 nationallicence 
700 1 |a Uhlig  |D Steffen  |u QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany  |4 aut 
700 1 |a Frost  |D Kirstin  |u QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany  |4 aut 
700 1 |a Colson  |D Bertrand  |u QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany  |4 aut 
700 1 |a Simon  |D Kirsten  |u QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany  |4 aut 
700 1 |a Mäde  |D Dietrich  |u State Office for Consumer Protection, Freiimfelder Str. 68, 06112, Halle (Saale), Germany  |4 aut 
700 1 |a Reiting  |D Ralf  |u Hessian State Laboratory, Druseltalstr. 67, 34131, Kassel, Germany  |4 aut 
700 1 |a Gowik  |D Petra  |u Federal Office of Consumer Protection and Food Safety, Mauerstr. 39-42, 10117, Berlin, Germany  |4 aut 
700 1 |a Grohmann  |D Lutz  |u Federal Office of Consumer Protection and Food Safety, Mauerstr. 39-42, 10117, Berlin, Germany  |4 aut 
773 0 |t Accreditation and Quality Assurance  |d Springer Berlin Heidelberg  |g 20/2(2015-04-01), 75-83  |x 0949-1775  |q 20:2<75  |1 2015  |2 20  |o 769 
856 4 0 |u https://doi.org/10.1007/s00769-015-1112-9  |q text/html  |z Onlinezugriff via DOI 
898 |a BK010053  |b XK010053  |c XK010000 
900 7 |a Metadata rights reserved  |b Springer special CC-BY-NC licence  |2 nationallicence 
908 |D 1  |a research-article  |2 jats 
949 |B NATIONALLICENCE  |F NATIONALLICENCE  |b NL-springer 
950 |B NATIONALLICENCE  |P 856  |E 40  |u https://doi.org/10.1007/s00769-015-1112-9  |q text/html  |z Onlinezugriff via DOI 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Uhlig  |D Steffen  |u QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Frost  |D Kirstin  |u QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Colson  |D Bertrand  |u QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Simon  |D Kirsten  |u QuoData GmbH, Prellerstr. 14, 01309, Dresden, Germany  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Mäde  |D Dietrich  |u State Office for Consumer Protection, Freiimfelder Str. 68, 06112, Halle (Saale), Germany  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Reiting  |D Ralf  |u Hessian State Laboratory, Druseltalstr. 67, 34131, Kassel, Germany  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Gowik  |D Petra  |u Federal Office of Consumer Protection and Food Safety, Mauerstr. 39-42, 10117, Berlin, Germany  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Grohmann  |D Lutz  |u Federal Office of Consumer Protection and Food Safety, Mauerstr. 39-42, 10117, Berlin, Germany  |4 aut 
950 |B NATIONALLICENCE  |P 773  |E 0-  |t Accreditation and Quality Assurance  |d Springer Berlin Heidelberg  |g 20/2(2015-04-01), 75-83  |x 0949-1775  |q 20:2<75  |1 2015  |2 20  |o 769