AOAC ISPAM Food Allergen WG Meeting Book (12-15-16)

AOAC ISPAM "Food Allergen" Working Group Questions/Comments Form

Submission Date

2016-12-08 06:29:31

First & Last Name

Markus Lacorn

Organization

R-Biopharm

E-mail Address

m.lacorn@r-biopharm.de

Date Submitted

12-16-2016

Question/Comment-1

Definiton: LoQ is not defined in an acceptable way since sufficient precision and acceptable recovery should be mentioned. The terms “sufficient” and “acceptable” depends on the method developer and shall be stated with numbers. Change: to be discussed by the group Definitions: mention that reproducibility is only characterized when a collaborative test was performed Change: include collaborative tests in the definition Definition “recovery”: Recovery may be characterized by spiking experiments because incurred materials are not available; this SMPR should allow spiked samples if there is no other possibilities; incurred should be preferred in any case System suitability: Quantitative ELISA systems always contain calibrators therefore it is not necessary to deliver an additional check sample; instead: It is recommended that every user of these kits establish his own control samples that fits his needs best. Reference Materials: Delete LGC materials since they are produced by a lab which is NOT ACCREDITED according to ISO Guides! Please refer to the “certificates” this lab delivers (only ISO 9001 is mentioned). Certifcates are available on request. The NIST materials are valuable.

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Question/Comment-6

Maximum Time-to-Result: Customers will not accept an assay e.g. with incubation times over night.