ISPAM September 6 2014 Meeting
Pre-decisional draft, do not distribute
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8. 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, or Health Canada Compendium of Official Methods ). Some aberrations may be acceptable if the aberrations are investigated, and acceptable explanations can be determined and communicated to method users.
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Draft Salmonella SMPR v12
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