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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