170135_inorganicventures_flipping

17.24 Method Validation

Confirm Basic Performance Criteria : Limit of Detec4on (LOD)

• Limit of Detec+on (LOD) is a criterion that can be difficult to establish. • The detec+on limit of the method is defined as 3*SD0, where SD0 is the value of the standard devia+on as the concentra+on of the analyte approaches 0. • The value of SD0 can be obtained by extrapola+on from a plot of standard devia+on (y axis) versus concentra+on (x axis) where three concentra+ons are analyzed ~ 11 +mes each that are at the low, mid, and high regions of interest. • This determina+on should be made using a matrix that matches the sample matrix.

17.25 Method Validation

Confirm Basic Performance Criteria : Sensitivity

• Sensi&vity or delta C = 2 (2)1/2 SDc , where SDc is the standard devia&on at the mid point of the region of interest. • This represents the minimum difference in two samples of concentra&on C that can be dis&nguished at the 95% confidence level.