OMA Consulting Protocol Review: OMACON-2019-2

2.5.9.3.2 RSD r = [s r /mean cand ] x 100

2.5.10 LOD and LOQ Determination

2.5.10.1 2.5.10.2

Graph s r vs. mean for the candidate method results.

Calculate the LOD as

( ) b s m

0 3.3 1 1.65 + −

X

LOD =

where is the mean analytical value of the known negative matrix; is the intercept of the plot; and is the slope of the plot. 0 X b s m

2.5.10.3

Estimate the LOQ as

LOQ = 3 x LOD

2.5.10.4

Validate the LOQ by spiking each matrix at or near the estimated LOQ and testing 10 replicates to demonstrate acceptable precision.

2.5.11 Acceptance Criteria 2.5.11.1

For each matrix evaluated, the following performance requirements as outlined in SMPR 2018.009 (Figure 1) should be met.

Figure 1: SMPR 2018.009 Performance Requirements

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