AOAC SPADA February 2015 Meeting Book

Pre-decisional draft, do not distribute

9. Method Performance Requirements (cont’d):

Table 2: Inclusivity/Exclusivity

Final Test Concentration (cfu/ml )

Minimum Acceptable Results

Parameter

Parameter Requirements

SLV: At least 100 Salmonella serovars cultured by the candidate method enrichment procedure

Inclusivity

100% positive results **

10-100 x AMDL

SLV: At least 30 non- Salmonella species cultured in non-selective broth.

overnight growth undiluted

100% negative results **

Exclusivity

Notes: SLV: Single-laboratory validation study.

** 100% correct analyses are expected. All aberrations are to be re-tested following internationally recognized guidelines (ISO 16140, AOAC OMA Appendix J, Health Canada XX). Some aberrations may be acceptable if the aberrations are investigated, and acceptable explanations can be determined and communicated to method users.

Draft Salmonella SMPR v15

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