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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