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subsequently determined to lack the genetic target of the ANSR assay by PCR analysis (Neogen Corp.,
unpublished results). All 38 non-salmonellae were correctly identified as “Not
Salmonella
spp.”.
In addition to pursuing Official Methods of Analysis status, an ultimate goal is inclusion of the method as
a
Salmonella
identification tool, as an alternative or adjunct to biochemical testing, in BAM and MLG.
The ANSR
Salmonella
confirmation test is proposed for use whenever confirmation of presumptive
Salmonella
spp. colonies is indicated, for example, in association with either reference culture methods
or rapid screening assays. To satisfy requirements associated with this objective, an inter-laboratory
collaborative study is proposed.
Collaborators
Twelve to fifteen collaborators will be recruited from a pool of candidates representing government
laboratories, private testing laboratories, and food company laboratories. Some, but not all, of the
collaborators are expected to have previous experience with the ANSR
Salmonella
assay as used in its
primary screening mode. Instructions to Collaborators are provided as a separate document (see
Appendix I).
Study Design
The study is designed in accordance with the
AOAC International Methods Committee Guidelines for
Validation of Microbiological Methods for Food and Environmental Samples
[5].
Number and Types of Samples
– Twelve bacterial cultures, including 6
Salmonella
spp. serovars and 6
non-salmonellae (see table below). Samples will be randomized and blind coded in the Study Director’s
laboratory. Samples will be supplied as pure bacterial cultures on agar slants with screw-cap tubes.
Samples will be shipped to collaborating laboratories by overnight delivery service using Category B
biohazard packaging and labeling, and stored at 2-8
o
C until the start of testing. Collaborators will be
provided with a Sample Receipt Form (see Appendix II) to complete and return to the Study Director,
acknowledging that samples were received in good condition.
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