Opinion on Allergy Alert Test (AAT) as a proof-of-concept study.

The SCCS acknowledges the standardisation of the allergy test offered by the proposed AAT as a prerequisite for possible future use of such a test by consumers. Within the precision limits of the study, it has been demonstrated that the rating of the test results by a well informed layperson corresponds well with that of a dermatology expert.

However, as the study participants may have constituted a selective, more educated, or motivated subset of the general user population, the effectiveness of the test in terms of general applicability to all consumers still needs to be demonstrated.

The diagnostic performance indicates a very good specificity, but a potentially moderate sensitivity, leaving room for the possibility of false-negative AAT reactions in sensitised consumers who may then experience allergic contact dermatitis to a subsequently applied product.

In addition, the results provided by the study can only partly enable assessment of the benefit and risk of the AAT for the consumers, and the SCCS cannot, at this stage, endorse the use of the AAT as an “alert” for contact allergy to hair dyes in consumers.

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