Evaluation of a Novel Rapid Test System for the Detection of Allergic Sensitization to Timothy Grass Pollen against Established Laboratory Methods and Skin Prick Test

Abstract

Type I hypersensitivity is driven by allergen specific immunoglobulin E (sIgE) and thus sIgE represents a marker for modern allergy diagnosis. Recently, a rapid assay for the detection of sIgE, termed as (Allergy Lateral Flow Assay) ALFA, has been developed. The objective of our study is the evaluation of a scanner-based system for the semiquantitative interpretation of ALFA results. Agreement to Skin Prick Test (SPT, Allergopharma), ALLERG-O-LIQ System (Dr. Fooke), and ImmunoCAP (Phadia) was investigated using 50 sera tested for specific IgE to timothy grass pollen (g6). 35/50 sera were positive by SPT, ALLERG-O-LIQ, and ImmunoCAP. Excellent agreement was observed between ALFA results and SPT, ImmunoCAP, and ALLERG-O-LIQ. Area under the curve (AUC) values were found at 1.0, and 100% sensitivity and specificity was found versus all other methods. Visual- and scanner-based interpretation of the ALFA results revealed excellent agreement.