Food Authenticity Program Meeting Book (March 13, 2020)
QUANTITATIVE PCR • For quantitative PCR methods, the basic performance characteristics are: – Extraction Efficiency – PCR Efficiency – Dynamic Range (Range of quantification) – Sensitivity (Limit of Detection-LOD) – Sensitivity (Limit of Quantification-LOQ) – Specificity (Selectivity) – Precision-Repeatability and Reproducibility Standard Deviations – Robustness – Trueness
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www.fda.gov
VALIDATION PARAMETERS FOR QUALITATIVE AND QUANTITATIVE PCR
L1-Emergency
L2 –SLV
L3- MLV
L4-MLV
Number of labs
1
1
8-10
Matrix sources per matrix
No. of spike levels
Replicates if matrix source = 1
Replicates if matrix source > 1
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www.fda.gov
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