Quantitative polymerase chain reaction in the bioanalytical laboratory and technical and scientific considerations for nonclinical and clinical assay characterization, validation and sample analysis

In this manuscript, the European Bioanalysis Forum reports back on their discussions on practical and scientific considerations related to bioanalytical applications of quantitative polymerase chain reaction. This publication follows an earlier publication in which the European Bioanalysis Forum recommends to consider principles of context of use when defining assay acceptance criteria for method validation criteria and sample analysis.

Automated summary

This manuscript summarizes the discussions of the European Bioanalysis Forum on practical and scientific considerations related to bioanalytical applications of quantitative polymerase chain reaction. It emphasizes the recommendation to consider principles of context of use when defining assay acceptance criteria for method validation criteria and sample analysis.