SPADA Working Groups ~ April Meeting Book

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

SPADA SEB Working Group 03/04/2015 Telecon – Meeting Minutes v1