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

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

2016-12-08 06:29:31

Markus Lacorn

R-Biopharm

12-16-2016

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.

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

times over night.