Validation of qualitative PCR methods on the basis of mathematical-statistical modelling of the probability of detection
Gespeichert in:
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)
Online Zugang:
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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 | ||