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© Romer Labs, 2016

8. Cross-reactivity

No cross-reactivity has been determined to maize, rice, teff, millet, buckwheat, quinoa,

amaranth, and soy in the initial validation. There has not been any incident which

confutes this.

Additionally, no further unknown cross-reactivities have been identified for this method.

9. Additional Validations

The Gluten G12 sandwich ELISA test was approved as official method by AACC

International (AACCI Approved Method 38-52.01).

The Technical Committee Report is attached.

10. Conclusion

The data above has shown that the G12 sandwich ELISA is capable of quantitating gluten

in foods. Gluten recovery has proven to be accurate over the whole quantitation range of

the ELISA method. Some matrix effects, especially with the incurred cookie samples may

lower recovery as compared to spiked samples, but results are still within the acceptable

range. There has not been any evidence that the method is not suitable for its intended

purpose as the results are consistent upon repeated measurements and within different

batches of the test kit.

According to these results, it is recommended that the method be accepted by AOAC as

Official Final Action.