ISPAM Stakeholder Panel Meeting Book 3-14-17

GLUTEN R5 Assay Kit Relative Response by Spiked Grain Weight

70.00

y = 0.2965x + 0.2085 R² = 0.9977

60.00

BARLEY SLOPE = 29.7%

50.00

y = 0.2362x + 2.4442 R² = 0.9893

40.00

RYE SLOPE = 23.6%

30.00

GLUTEN PPM

20.00

WHEAT SLOPE = 10.3%

y = 0.1034x + 0.8348 R² = 0.999

10.00

0.00

0

50

100

150

200

SPIKE PPM

Barley

Rye

Wheat

Linear (Barley)

Linear (Rye)

Linear (Wheat)

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ACCURACY STRATEGY

• Response of prospective method should be evaluated for 3 grains independently. • Experimental evaluation should be performed on grain (flour) spiked into oat flour, and extracted as per proposed kit extraction method. • Samples of spiked material could be made by 3 rd party lab and made available to researchers, along with non-ELISA “reference” values. • Results of these experiments have shown much lower RSDs than we see in practice, so this experiment will not be useful for estimating precision. • Because of the uncertainty in everything, the acceptance criteria for this approach will need to be very wide. • This approach is probably best done as part of single lab validation or single lab with independent lab verification, along with some sort of cross-reactivity study.

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