Reliability of a novel electro-medical device for wheal size measurement in allergy skin testing: An exploratory clinical trial

Abstract

Skin prick testing (SPT) is the cornerstone of IgE-mediated allergy diagnosis,1 due to its high sensitivity and specificity.2 However, a uniform method for wheal measurement does not exist. Ansotegui et al.2 recommends to measure wheals in millimeters with a ruler, in many centers they are outlined with a pen and transfer by tape to a paper and then measured. Subsequently, the specialist is able to manually measure the maximum (MD) and orthogonal diameter (OD) of the wheal. This procedure is time consuming and makes repro-ducible measurements difficult.2,3 Knowing the wheal's area could help make a more accurate diagnosis.4 Over the last 30 years, many attempts have been made to develop a device to measure the size of SPT.3 Nexkin DSPT® (Figure S1A,B) is a novel mechatronic system based on 3D laser technology, that automatically locates allergen's wheal and measures its size (MD, OD and area in square millimeters) (Figure S1C).