Pre-decisional draft, do not distribute
1
Draft
Salmonella
SMPR v15
AOAC Standard Method Performance requirements2014.XX, Version 15; September 6, 2014
Method Name:
Detection of
Salmonella
species in romaine lettuce and baby spinach.
Purpose:
AOAC SMPRs describe the minimum recommended performance characteristics and
suggested inclusivity/exclusivity organisms to be used during the evaluation of a method. The
evaluation may be an on-site verification, a single-laboratory validation, or a multi-site collaborative
study. SMPRs are written and adopted by AOAC Stakeholder Panels composed of representatives from
the industry, regulatory organizations, contract laboratories, test kit manufacturers, and academic
institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their evaluation of validation study
data for method being considered for
Performance Tested Methods
or AOAC
Official Methods of
Analysis
, and can be used as acceptance criteria for verification at user laboratories.
Add
Reference to
Appendix F.
Approved Body:
AOAC International Stakeholder Panel on Alternative Methods (ISPAM)
Approval Date:
Final version date:
1.
Intended Use
:
Routine surveillance and monitoring by a trained technician.
2.
Applicability:
Alternative methods used to detect
Salmonella
species and their serovars
in
pre-harvest field samples of romaine lettuce and baby spinach.
3.
Analytical Technique
:
Any analytical technique that can meet the performance requirements.
4.
Definitions
:
Alternative Method
Method of analysis that demonstrates or estimates, for a given category of products, the same
analyte as is measured using the corresponding reference method. The method can be a
proprietary or non-commercial, and does not need to cover an entire analysis procedure, that is
from the preparation of samples to the test report.
1
An ISO term used to denote the method to be evaluated against a “reference” method. AOAC uses
the term “candidate” method for the same purpose in its guidelines. The
terms “alternative” and
“candidate” methods are interchangeable for the purposes of this SMPR.
Acceptable Minimum Detection Level (AMDL)
The predetermined minimum level of an analyte, as specified by an expert committee which must
be detected by the alternative method with an estimated 5% lower confidence limit on the
probability of detection (POD) of 0.95 or higher. The AMDL is dependent on the intended use.
2
1
FDIS 16140-2 (2014): Microbiology of the food chain — Method validation — Part 2: Protocol for the validation
of alternative (proprietary) methods against a reference method
2
Footnote 2 should be: FDIS 16140-1 (2014): Microbiology of the food chain — Method validation — Part 1:
Vocabulary
