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Annex 4. FAO/WHO 2001 Decision Tree


Footnotes

Any positive results obtained from sequence homology comparisons to the sequences of known allergens in existing allergen databases or from serum screening protocols, both conducted in accordance with the guidelines established in Sections 6.1, 6.2 and 6.3, indicate that the expressed protein is likely allergenic.



The degree of confidence in negative results obtained in the specific serum screen is enhanced by the examination of larger numbers of individual sera as explained in Section 5.3. Conducting the specific serum screen with small numbers of individual sera when larger numbers of such sera are readily available should be discouraged.



When positive results are obtained in both the pepsin resistance and animal model protocols, the expressed protein has a high probability to become an allergen. When negative results are obtained in both protocols, the expressed protein is unlikely to become an allergen. When different results are obtained in the pepsin resistance and animal model protocols, the probability of allergenicity is intermediate, although rational explanations may be possible in some situations.


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