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ISPAMWORKING GROUP CHAT COMMENTS/QUESTIONS:
November 30, 2016
11:00-1:00pm ET
Yumin Chen: since this is an ELISA method. do we need the term of "two ion MS/MS transition" in
Method detection Limit? Does it mean a MS method is needed to confirm the method detection limit?
Laura Allred: I don't have the Abbott paper in front of me. Does it cover a definition of "Whole Egg
Allergen", or do we need to discuss that here?
Yumin Chen: In light of FSMA, do we envision it is to be used for FSMA compliance?
Laura Allred: I am in agreement with Paul.
Laura Allred: Do we want to use "allergen" instead of "protein"?
France Cho: MDL is a statistically calculated value. We will need to spike at that level to verify if the
amount can be seen or not. If recovery is low, result will be biased low, therefore false negative
Markus L: I agreee with Laura: proteins
Bert Popping: It should include both, as Paul said, provided validation data are available for both
Laura Allred: environmental swabbing should be covered in the qualitative SMPR
Bert Popping: Yes
Diana Kavolis: Can we consider applicability as quant of whole chicken egg. (not specify allergens perse
as we test a whole entity and would need to validate on spikes with whole items not purified proteins.