Microbiology-PTM-OMA_Modules_1-5

Harmonized Studies:  Qualitative cont’d

Type of Analysis

AOAC RI PTM Validation

AOAC OMA Validation* ISO 16140‐2 Validation

8– Noninoculated Control 8 – Low (Fractional) 8 ‐ High  Minimum of  10 Valid Data Sets 

12– Noninoculated Control 12 – Low (Fractional) 12 ‐ High  Minimum of  10 Valid Data Sets 

Inter‐Laboratory  Study

NA

RLOD, Specificity,  Sensitivity,

POD, LPOD, dLPOD, s POD

Relative Trueness,  False Positive Ratio *Per the recommendation of the Expert Review Panel for Microbiology, 8 replicates per contamination level  will be acceptable for an inter‐laboratory study, although 12 is preferred.