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on to “Validation Guidance,” where the word “roughly” was removed and SEC was clarified include
to SEC 1, SEC 2, and SEC 3. The group agreed that this assay needs to be specific to SEA-C and does
not detect D and onwards. Witzenberger highlighted that SEE is one of the stronger cross reactions
there is, although it is very rare.
IV.
Adjourn
The meeting adjourned at 3:00 p.m. EST and the group agreed to meet again on March 25 at 2:00
p.m. EDT.
MARCH 4, 2015 SPADA SEB WG MEETING: ACTION ITEMS
Action
Owner
Schedule follow up call or March 25.
AOAC
Incorporate today’s changes into SMPR
AOAC / Tallent