Question
Asked by
To ask Her Majesty's Government what will be the impact of the development of over-the-counter self-diagnostic tests for food allergy on NHS allergy services; and what safeguards exist to ensure patients receive an accurate diagnosis and appropriate advice. [HL2965]
The Department of Health has not carried out, nor does it have any current plans to carry out, any investigation on the impact of the development of over-the-counter self-diagnostic tests for food allergy on National Health Service allergy services.
Over-the-counter self-diagnostic test kits for allergy to food placed on the market for use by the lay person must meet the safety, quality and performance requirements of the Medical Devices Regulations. Instructions for use for such test kits should warn users of possible false results and provide guidance on the interpretation of the results and the need for medical advice. The results of the tests must be expressed and presented in a way that is readily understood by a lay person.