Microneedles for allergy skin testing: Comprehensive analysis of agreement, accuracy, and pain

Background The skin prick test (SPT) is a standard method for identifying allergic sensitization. However, pain and needle phobia often compromise pediatric compliance. Microneedle devices offer a minimally invasive alternative to conventional lancets.Objective We evaluated the agreement, diagnostic accuracy, and patient tolerability of a novel microneedle compared to a lancet for SPT.Methods Subjects with allergic rhinitis underwent SPT using both devices with Dermatophagoides pteronyssinus (Dp) extract, histamine, and saline controls. Net mean wheal diameters (MWD) were calculated by subtracting the saline MWD from the Dp and histamine MWDs. Agreement was assessed by Bland-Altman analysis and Cohen kappa (k), diagnostic performance by receiver operating characteristic analysis, and pain by a visual analog scale.Results Of 150 subjects (aged 8-60 years), 53.3% were sensitized to Dp. Both devices produced significantly larger Dp and histamine MWDs than saline MWD (P Dp MWD was smaller with microneedle (2 [0-8.13] mm) than lancet (4 [0-12.5 mm], P Dp MWD, Bland-Altman analysis indicated a mean bias of -2.1 mm for microneedle, with 93.3% within the limits of agreement. With lancet used as the reference, the microneedle had an area under the curve of 0.904. At a 3 mm cutoff, sensitivity was 82.5%, specificity 94.3%, and accuracy 86%. Interdevice concordance was good (k = 0.76). Median pain scores were significantly lower for microneedle (2.5 [0-9]) compared to lancet (8.0 [1-26], P Conclusion The microneedle demonstrates high diagnostic performance and good concordance with the standard lancet while significantly reducing pain, thus supporting its utility in pediatric and needle-averse populations.