RI-ERP-FINALACTION-Recommendations

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

Table 10. Results for naturally contaminated corn flour samples (ethanol extraction); 20 replicates and 20 separate extractions per concentration

mg gliadin/kg

result for each repeat

POD

- - - -

- - - -

- - - -

- - - -

-

-

0,11

0,00

- -

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

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

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

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

0,98

1,00

2,07

1,00

4,66

1,00

6,35

1,00

Table 10 gives an overview on the results obtained for the naturally contaminated corn flour samples (containing an unknown source of gluten). Since there is a clear cut-off at 0.98 mg gliadin per kg, and no variation regarding false-positives or false-negatives was observed, a POD response curve is therefore not provided. Table 11 gives an overview on the results obtained for the incurred snack samples (corn basis, containing wheat flour; extracted with Cocktail). Since a POD response curve does not give any further information on the results, it is not provided. In this case a gliadin concentration of 2.2 mg/kg is in all 20 cases positive. Once again, it is really hard to establish a concentration, where 50% of all samples are positive and 50% are negative. Therefore the results are only descriptive. A calculation of a POD95% is not possible or accompanied with a high level of uncertainty. Samples between 0 and 1.4 mg/kg are hard to check for homogeneity by the quantitative ELISA because the assay variation is higher than the homogeneity to be characterized.

POD AOAC Research Institute Expert Review Panel Use Only - - - - - - - - + - result for each repeat 0,00

Table 11. Results for incurred snack samples (Cocktail extraction); 20 replicates and 20 separate extractions per concentration

mg gliadin/kg

- - - - - - - -

- - - - - - -

- - - - - - - -

0,00

-

- -

1,40

0,15

-

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

+

-

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

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

2,20

1,00

5,70

1,00

17,70

1,00

Page 21 of 27

RIDA®QUICK Gliadin Validation report 2015-01-14