532 / 1195
4
Yes, with the minor changes as recommended.
5
Yes pending complete exclusivity data.
6
Yes, this method may be adopted for First action Status
7
If concerns outlined above are satisfactorily addressed to those present for the discussion of the study, then I
would support First Action status for this method.
AFTER FIRST ACTION STATUS:
Reviewer #
Is there any additional information that the ERP should consider in order to recommend
the method for Final Action status?
1
No
2
Intra-laboratory test the 4 new Listeria species.
3
4
Not that I am aware.
5
6
7
Follow normal protocols, soliciting information on the performance of the method from users.
Reviewer #
Comments:
1
2
3
No additional comments.
4
5
6
7
SAFETY
The additional risks identified require clarification(s) so as to ensure that the manuscript corresponds
to the approved study protocol and safety guidance
(See comment):
Comment:
A safety caution is included in the VIDAS LPT package insert and the CDC website is cited in the
references, while in the pre collaborative study (Appendix 2) a safety caution is included in the text.
It may be helpful that users have a safety caution in the method where they are directed to the CDC
website for biosafety information dealing with pathogens
http:/www.cdc.gov/biosafety/publications/bmb15/index.htm/
STATISTICS
8
21 June 2013