Pre-decisional draft, do not distribute
148
8.
Method Performance Requirements (cont’d):
149
150
Table 2: Inclusivity/Exclusivity
151
Parameter
Parameter Requirements
Final
Test Concentration
(cfu/ml
)
Minimum Acceptable
Results
Inclusivity
SLV: At least 100
Salmonella
serovars
cultured by the candidate method
enrichment procedure
10-100 x AMDL
100% positive results
**
Exclusivity
SLV: At least 30 non-
Salmonella
species
cultured in non-selective broth.
overnight growth
undiluted
100% negative results
**
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.
152
153
154
155
156
157
5
Draft
Salmonella
SMPR v12
