RI-ERP-FINALACTION-Recommendations

OMAMAN-20 C/ In House Validation Report ERP Use Only - March 2015

Table 1. Results for target compounds (extracted with 60% Ethanol according to 3.7.2.3); the sample concentration given in mg/kg is the concentration of prolamins in the extract (determined by the reference ELISA) multiplied with the dilution factor during sample preparation. It is therefore a simulation of a gluten-free matrix containing the target compounds at these concentrations. WGPAT means the gliadin reference preparation.

Extract [µg/mL]

Sample [mg/kg]

WGPAT Wheat

Rye

Barley

0,00 0,00 0,00 0,00 0,00 0,05 0,05 0,05 0,05 0,05 0,10 0,10 0,10 0,10 0,10 0,20 0,20 0,20 0,20 0,20 0,40 0,40 0,40 0,40 0,40 0,80 0,80 0,80 0,80 0,80

0,0 0,0 0,0 0,0 0,0 0,5 0,5 0,5 0,5 0,5 1,0 1,0 1,0 1,0 1,0 2,0 2,0 2,0 2,0 2,0 4,0 4,0 4,0 4,0 4,0 8,0 8,0 8,0 8,0 8,0

- - - - - - - - - -

- - - - - - - - - -

- - - - - - - - - - - - - - -

- - - - - - - - - - - - - -

+ + + + + + + + + + + + + + + + + + + +

+

-

+ + + + + + + + + + + + + + + + + +

+ + + + + + + + + + + + + + + +

+

-

+ + + + + + + + + + + + +

AOAC Research Institute Expert Review Panel Use Only

From these results it is clear that the dip-stick detects all three claimed target compounds with a comparable sensitivity. As expected there is no difference between the WGPAT gliadin and wheat. The small difference of about 2 between the sensitivities for WGPAT-gliadin and wheat on one hand and rye and barley on the other hand could be explained by a different behaviour of each matrix extract during the immuno-chromatographic process (e.g. flow rate). Since there is some variation in the results and sensitivities, POD curves are provided in Fig. 2.

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RIDA®QUICK Gliadin Validation report 2015-01-14