Microbiology-PTM-OMA_Modules_1-5

PTM and OMA SLV Study Designs

Method Type Study Design

Statistics

Acceptance Criteria Expert Judgement

50 target strains (100 if  Salmonella spp) 100x LOD; all claimed enrichments

None ‐ specifically report  negative inclusivity and  positive exclusivity strains None ‐ specifically report  negative inclusivity and  positive exclusivity strains

Qualitative

30 non‐target species  stationary growth in non‐selective media Quantitative 50 target strains (100 if  Salmonella spp) 100x LOD in non‐selective media

Expert Judgement

30 non‐target species  stationary growth in non‐selective media Identification* 25‐200 target strains depending on target None ‐ specifically report  100 non‐target strains *Preference is to follow ISO 16140‐6 for number and types of strains, dependent on the analyte claim. negative inclusivity and  positive exclusivity strains

Expert Judgement

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