A novel poisson distribution-based approach for testing boundaries of real-time PCR assays for food pathogen quantification

J Food Prot. 2011 Sep;74(9):1404-12. doi: 10.4315/0362-028X.JFP-10-458.

Abstract

The validation of quantitative real-time PCR systems and above all, proof of the detection limit of this method, is a frequently and intensively discussed topic in food pathogen detection. Among proper sample collection, assay design, careful experimental design, execution of real-time PCR, and data analysis, the validation of the method per se ensuring reliable quantification data is of prime importance. The purpose of this study was to evaluate a novel validation tool for real-time PCR assays, based on the theoretical possibility of the amplification of a single DNA target. The underlying mathematical basis for the work is Poisson distribution, which describes patterns of low particle numbers in a volume. In this context, we focused on the quantitative aspect of real-time PCR for the first time. This allowed for demonstration of the reliable amplification of a lone target DNA molecule and the demonstration of the distinct discrimination between integer molecular numbers when using low initial copy numbers. A real-time PCR assay amplifying a 274-bp fragment of the positive regulatory protein A locus of Listeria monocytogenes was used for this work. Evidence for a linear range of quantification from a single target copy to 10 ng of target DNA was experimentally demonstrated, and evidence for the significance of this novel validation approach is presented here.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • DNA, Bacterial / chemistry
  • DNA, Bacterial / genetics
  • Food Contamination / analysis*
  • Food Microbiology
  • Gene Amplification
  • Humans
  • Listeria monocytogenes / isolation & purification
  • Poisson Distribution*
  • Polymerase Chain Reaction / standards*
  • Sensitivity and Specificity
  • Species Specificity

Substances

  • DNA, Bacterial