Food Authenticity Program Meeting Book (March 13, 2020)
METHOD VALIDATION DOCUMENTS
For Qualitative and Quantitative PCR-Based Assays: Assay Design • Type of assay: oligonucleotide probe-based or double stranded DNA dye-based • Name of target gene or region • Internal control/amplification control type: exogenous or endogenous • Exact oligonucleotide sequences for all primers and probe(s) • Length of PCR product (amplicon) • Dye and probe characteristics. (Dyes used and probe chemistries etc.).
29
www.fda.gov
METHOD VALIDATION DOCUMENTS CONT’D
Sample Preparation and nucleic acid Extraction • Form and quantity of sample required. Include information on subsampling or sample compositing as well as relevant aspects of handling and storage. • Method or kit used for DNA extraction. Include any relevant modifications as well as information on RNAse treatment.
30
www.fda.gov
Made with FlippingBook - professional solution for displaying marketing and sales documents online