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Appendix 1: Evaluation of Commercially Available Analytical Methods for Proteins from Major Food Allergen

Validationb

Sensitivity (LODc)

Quantitation (LOQc) (ppm)

Raw and Processed

Species Specificity

Protein(s) Detected

No

(ppm) 2.5

2.5

Foods? Yes

Not reported

Not reported

0.5% soy protein in food sample Not reported

0.5% soy protein in food sample

Not reported

Not reported

Not reported

0.005

Not reported

shrimp, crab, lobster and scampi. Not reported

Tropomyosin

0.05

0.05

Yes (for

Tropomyosin

Manufacturera

Method

Neogen

Veratox for

Soy Flour

Tepnel

Soya Protein

No

Allergen

No

Crustaceans

specified foods)

Fish No commercial methods are available. See Appendix 4 for gluten methods. No other commercial methods are available. Information from manufacturers web sites, except for information on the Elisa System Crustacean test kit from FDA Docket #2005N-0231, comment number EC1. MLPT – Multiple Laboratory Performance Tested; JRC- European Commision Joint Research Centre; AOAC = AOAC International. LOD = Limit of detection, LOQ = Limit of quantiation. Wheat a b c

Abkem Iberia

Crustacean DiagnoKit

Elisa Systems

Crustacean (18 species)

No

Practicality

Yes

Yes

Yes

Yes

Revised Threshold Report

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