Food Authenticity Program Meeting Book (March 13, 2020)

METHOD VALIDATION DOCUMENTS CONT’D

Data Analysis • Specify which software program was used for data analysis. • Report and explain any adjustments made to baseline and threshold determination, or other software default analysis parameters. • For dsDNA dye based assays, analysis of melt curves must be performed to confirm the presence of a single, sharp melting peak.

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METHOD VERIFICATION Verification of method performance is defined for two situations: • Verifying performance with each analytical batch • The first use of a standard method within the laboratory

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