Determination of multiple allergen-specific IgE by microfluidic immunoassay cartridge in clinical settings

Abstract

Our aims were to evaluate the performance of an automated microfluidic immunoassay system for measuring allergen-specific IgE (sIgE) in sera against an established in vitro assay and to assess the system's diagnostic accuracy against objective clinical criteria for identifying sensitization to specific allergens in daily practice of allergy clinics. Using both the automated microfluidic-based immunoassay system (BioIC and ImmunoCAP, we measured sIgE in serum samples from 212 children who visited allergic clinics in two medical centers. Outcomes of skin prick tests (SPT) served as the clinical comparison method. The assay results of targeted allergen of BioIC have a good correlation with ImmunoCAP in the diagnosis of allergen sensitivity by patients' clinical history. When comparing the test results of the sIgE against overall allergens, in either two tests among the three assays performed showed high percentage of agreement between BioIC and ImmunoCAP (77.8%, 95% CI: 72-83.3%) but not with SPT (BioIC 64.9%, 95% CI: 58-72%; ImmunoCAP 67.5%, 95% CI: 61-74%). Using ROC analysis and SPT as quasi-standard, BioIC and ImmunoCAP have nearly the same performance of sensitivity and specificity in the confirmation of SPT results. The total and within one-class agreements of each allergen test result between BioIC and ImmunoCAP ranged between 55.2% and 99.5% with an overall average of 80.9%. Laboratory testing for sIgE can be performed on a fully automated, microfluidic cartridge system with advantages of low sample volume, simultaneously tested allergens, and with diagnostic accuracy for representative allergens equivalent to the semi-automated CAP technology.

Children with atopic dermatitis show clinical improvement after Lactobacillus exposure

“…Skin prick tests with commercial allergen extracts of egg, milk, crab, mite, cockroach, and animal dander were performed [13]. Serum biomarkers, such as allergen-specific IgE levels, IFN-r, IL-4, TGF-b, and TNF-a levels were measured by enzyme-linked immuno-sorbent assay [14]. Urine eosinophilic protein X (EPX) and 8-OHdG were also measured by immuno-fluorometric assay [15,16].…”

Tobacco smoke exposure and multiplexed immunoglobulin E sensitization in children: a population‐based study

“…Serum levels of allergen‐specific IgE were obtained using a newly launched automated microfluidic‐based multiplexed immunoassay (BioIC TM Allergen‐specific IgE Detection Kit‐ AD40 Panel; Agnitio Science and Technology, Hsinchu, Taiwan), a reliable method providing similar results to those of ImmunoCAP with an average of 80.9% for total and within one‐class agreements of each allergen test . The BioIC ™ allergen‐specific IgE detection system is an integration of three advanced technologies: automatic microfluidic liquid handling, chemiluminescent labeling, and parallel multiplexing IgE assays . Allergen extracts were dotted in duplicate onto cartridges.…”

Evaluación de técnicas inmunológicas in vitro para el diagnóstico de alergias: metanálisis 2000-2012

“…En la primera la IgE se fija a la superficie del basó-filos permitiendo la reacción con antíge-nos específicos y en la segunda la IgE se fija al antígeno implantado en una matriz donde se realizara la prueba de identificación [39][40][41][42] .…”