Chemistry-PTM-OMA_Modules_1-4

PTM and OMA SLV Matrix Study Designs

Method Type Study Design

Statistics

Acceptance Criteria Determined by  SMEs; suggested  recovery and  precision criteria in  OMA Appendix K 95% CI on dPOD must  include 0 if method  comparison If no reference  method, determine  lowest concentration  that yields POD = 1.0.

Recovery, bias, LOD,  LOQ, s r Regression analysis  per matrix

Quantitative All claimed matrixes in MD lab; 1/5 matrixes  in IL; co‐fortification if multianalyte method 4‐6 concentrations (incl 0) 5 replicates per concentration Qualitative All claimed matrixes in MD lab; 1/5 matrixes  in IL; co‐fortification if multianalyte method ≥6 concentrations (incl 0) – 2 concs yielding  fractional positive results* 20‐30 replicates per concentration *Fractional positives are defined as POD = 0.25‐0.75

Intermediate  reproducibility Probability of  Detection (POD)