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More research needed on new allergy test, says NICE

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The National Institute for Health and Care Excellence has issued draft diagnostics guidance recommending against the routine use, at present, of a new allergy test by the NHS.

The institute said in draft guidance that further research was needed on the clinical effectiveness of the promising new test to help diagnose allergy.

“A test available in the NHS that could help identify multiple allergens simultaneously would be an important development”

Mirella Marlow

The ImmunoCAP ISAC 112 test, used with standard clinical assessment, is designed to simultaneously identify antibodies in the blood to 51 allergens that provoke reactions.

When a person is sensitised to two or more allergens, the institute noted that the cause of allergy could be difficult to diagnose because the immune system reacts to other allergens as they are similar in shape and structure to the causal allergen.

However, the guideline advisory committee concluded that, although the ImmunoCap ISAC 112 test shows promise, more research is needed to demonstrate its clinical effectiveness in helping healthcare professionals diagnose and assess suspected allergy.

The NICE draft guidance on the test, manufactured by Thermo Fisher Scientific, is open for consultation until 2 February.

NICE also considered Microtest, manufactured by Microtest Dx, for multiplex allergen testing, but concluded there was insufficient evidence to determine its effectiveness.

The draft guideline stated: “The ImmunoCAP ISAC 112 shows promise and further research is recommended on the clinical effectiveness of using it in people with allergy that is difficult to diagnose. Microtest is a new technology and further research by the company to show its clinical effectiveness is encouraged.”

Mirella Marlow, device and diagnostics systems programme director at NICE, said: “We are seeing more and more people, particularly children and young people, with allergy. These can be difficult to diagnose because often people are sensitive to multiple allergens and because many of the symptoms of allergy are common to other complaints.

“There is currently wide variation in the provision of NHS allergy services in England, particularly in primary care and in access to allergy specialists,” she said. “Allergy testing is also available through commercial routes and private medical care.

“The problems arise when there isn’t the necessary support or expertise for correct interpretation of the results and this could lead to people being placed on restriction diets unnecessarily,” warned Ms Marlow.

“A test available in the NHS that could help identify multiple allergens simultaneously would, therefore, be an important development,” she added.

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