7 / 134
SPADA SEB Working Group
03/04/2015 Telecon – Meeting Minutes v1
SPADA SEB Working Group
Meeting Minutes
Wednesday, March 4, 2015; 2:00 p.m. – 3:00 p.m. EST
Attendees
Panel Members
(Present during all or part of the
meeting)
:
AOAC Staff
(Present during all or part of the meeting)
:
Sandra Tallent, FDA (Chair)
Ryan Cahall, Censeo Insight
Martha Hale, USAMRIID
Malcolm Johns, DHS
Saleem Khan, University of Pittsburgh
Katalin Kiss, ATCC
Matthew Lesho, Luminex
Stephen Morse, CDC
Roberto Rebeil, ECBC
Reinhardt Witzenberger, R-Biopharm
Scott Coates
Christopher Dent
Krystyna McIver
Meeting Minutes
I.
Welcome and Introductions
All were welcomed, roll call was taken and the meeting commenced at approximately 11:00 a.m.
EST.
II.
Review of Last Meeting and Fitness for Purpose
Dent advised that minutes from the in-person meeting are still in the approval process but will be
released very soon. Coates provided a verbal summary of changes made to the draft SMPR at the
last meeting.
III.
Consideration of Method Performance Criteria
Tallent then led the group in further revising the SMPR document. Coates asked if it is detrimental
to write a standard that allows for detection of other toxins but concenterates on SEA, B and C? All
agreed that the other toxins do not create aerosol problems and therefore do not need to be
included. The method name remained “Detection of SEA-C.”
Definitions were then reviewed. The group discussed the definition for Maximum Time to
Determination. The group agreed that time to result should start from recovery of the toxins. The
definition was modified to read “Maximum time to complete an analysis starting with recovery of
toxins from the collection matrix and ending with the assay result.” A minor change was also made
to the Selectivity Study to include “related toxins.” All definitions were agreed and the group moved