National Research Council of Italy

Institute of Biosciences and BioResources

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IBBR publication #1887

Multiplex IgE diagnostic test performances compared to singleplex

Mari A, Mitterer G, Rafaiani C, Ciancamerla M, Alessandri C, Bernardi ML, Giangrieco I, Tuppo L, Zennaro D, Ferrara R, Tamburrini M, Ciardiello MA, Harwanegg C

Allergy 72: 665-665. (2017)

Introduction:Laboratory allergy testing systems for IgE detectionare evaluated for standard parameters and performances. Multiplexis the new generation of multiplex IgE detection systems based onallergen preparations coupled on nano-beads using molecules andextracts. The best way to understand the performances of a newsystem is to compare with others.Objectives:To report the comparative evaluation of the multiplexIgE test versus the most used singleplex IgE testing systems.Results:The evaluation of the IgE binding was obtained by usingan Allergen IgE (BL-IgE), a standard polyclonal commercial product.BL-IgE is supplied after being tested on the 3 IgE testing systems.IgE mean values and ranges are provided. The product data sheetshows IgE values for 15 allergen extracts. 12 were used: Alt a, Ara h,Art v, Asp f, Bet v, Bos d, Can f, Der p, Equ c, Fel d, Gal d, Phl p.BL-IgE was tested on 22 consecutive multiplex batches, and extractto extract comparison was performed when the same was availableon FABER. FABER IgE, expressed as arbitrary units (FIU) gave thefollowing results: Ara h, overlapping with CAP-IMM-HYT; Art v,slightly below CAP, overlapping with IMM, above the HYT; Bet v,slightly below CAP-IMM; Bos d, above CAP-IMM-HYT; Can f,slightly below CAP-IMM, overlapping with HYT; Fel d, reproduciblebut below the three systems; Gal d, below IMM, overlapping withCAP-HYT; Phl p, overlapping with CAP-IMM. Alt a 1 performed bet-ter than CAP-HYT, overlapping with IMM. The 6 Der p FABER aller-gens gave overlapping results with the 3. Although reproducibleresults were record with Equ c FABER extract, average values alwaysfell below the range of the three systems. Asp f values were hardlyreproducible and always below the three systems, but the use of asimilar extract, Asp n, and the Asp r 1 allergen supported the Asp fIgE detection. A plus value of our study was to disclose IgE bindingto allergens not declared in the BL-IgE data sheet (e.g. Cup a 1, Prup 3), mostly all the molecule detected specificities (e.g. mite aller-gens) and all the IgE co-recognized preparations (e.g. eggs).Conclusions:The three systems having different reference stan-dards do not overlap each other. FABER IgE measurements performsvery well with most allergens, but improving the quality of someextracts will lead to better FABER performances. The multiplex IgEdetection is useful to disclose unknown sensitizations.

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