Comments on the Detection of Salmonella SMPR
5
Annex I
Inhibition control: This may need to be
reworded. Can the sample positively impact
the ability to detect? If not, then state that
inhibition is what is being controlled for.
The working group decided to eliminate Annex
I.
Annex I removed.
Annex II
This appears to be the main content of the
document – the provision of a standard list of
strains recommended for use. However,
where are the culture collection numbers?
How are the readers to obtain the strains?
What if a different set of strains were used in
the validation study?
The working group decided not to specify
culture collection numbers so that method
developers/validation could use their own
libraries of serovars and species.
No change proposed.
Annex II
CDC Top 20: Some of the numbers in this
column are not centered and FDA should be
define.
Agreed. Justify entries in the columns.
Revised in version 14
Annex II
All genus and species names should be
italicized.
Agreed. All references genus, species and
subspecies names should follow convention.
Pending. Can be
formatted when ready for
publication.
Annex II
Footnote 2 - Define acronym CDC
Agreed. Define "CDC".
Revised in version 14
Annex II
It is accepted practice to italicize all genus,
species and subspecies names but not serovar
names which should have a capitalized first
letter. For example entry 37, 48, and 89
serovars should be "Indiana, Infantis" and
"Inverness" respectively. In entries 3, 12, 19
change subspecies name 'Salamae' to
'salamae'. Conventionally 'subsp., spp., sp.,
var., and serovar.' are not italicized.
Agreed.
Revised in version 14
Annex II; #3
There would need to be more information for
the non enterica subsp organism than just the
O group. The past few times that we have
done a validation or an inc/exc study reviewers
required the antigenic formula for the non
enterica subsp.
Reporting the antigenic formula would be
dependent upon the individual strains used in a
study and could vary. As long as Salamae is
represented as a subspecies, this would still
allow method developers to utilize strains from
different collections.
No change proposed.
Annex II; #21
This serovar is now recognized as
Westhampton var 15+
Agreed.
Revised in version 14
Annex II; #46
If this is the organism from the Mango
outbreak this is the correct spelling is
Braenderup.
Agreed.
Revised in version 14
Annex II, #50 Spelling is Mbandaka
Agreed. Change to "Mbandaka".
Revised in version 14
Annex II, #62
This should be deleted. It causes fowl typhoid,
a severe disease in fowl that is usually tightly
controlled due to its animal health
implications.
The working group decided that this serovar
should remain on the inclusivity panel.
No change proposed.
