Comparative Clinical Performance of Multiple-Head Skin Prick Test Devices: A Prospective Evaluation of Pain, Sensitivity, Specificity, and Intradevice Variability

Background and objective Multiple-head skin prick test (SPT) devices are essential tools for percutaneous allergy testing; however, significant interdevice variability exists that may affect diagnostic accuracy, clinical performance, and interpretation. Intradevice variability, characterized by inconsistent responses across individual test heads, may lead to false-positive or false-negative results, potentially compromising allergen identification and treatment planning. This prospective study compared four FDA-cleared multiple-head SPT devices with respect to pain perception, histamine sensitivity, glycerin specificity, and intradevice variability to identify clinically meaningful performance differences. Methods Thirty healthy adults participated in this institutional review board-approved study (approval 33-098). Participants were tested with two 10-head devices (AllerTest-10 (MedScience Research Group, Inc., West Palm Beach, FL, USA; distributed by ALK-Abelló, Inc., Port Washington, NY, USA) and Skintestor OMNI (Greer Laboratories, Inc., Lenoir, NC, USA)) and two eight-head devices (AllerTest-8 (MedScience Research Group, Inc.; distributed by ALK-Abelló, Inc.) and Multi-Test II (Lincoln Diagnostics, Inc., Decatur, IL, USA)). Pain was assessed using a Visual Analog Scale (VAS; 0-10). Histamine (1 mg/mL) and glycerin controls were applied to volar forearm surfaces. Sensitivity was defined as a histamine wheal ≥3 mm, and specificity as a glycerin wheal