Full automation in allergy testing: measurement of specific IgE by the ENEA System.

We evaluated the ENEA System, a fully automated instrument for the measurement of specific IgE antibodies. The instrument dispenses sera and reagents, incubates, washes, and reads and prints results automatically. The "core" of the instrument is the reactive unit called ACE (Allergy Chamber Enzymatic), which is a new solid phase to which the allergens are linked. The system uses calibration curves specific for the major allergen families, and data are supplied qualitatively (five classes) and quantitatively. We evaluated the analytic efficiency of the system and its correlation with the in vivo test (skin prick test (SPT)) results in 60 patients with inhalant allergic diseases and in 20 controls. Results: 450 results were available within 4 h. A satisfactory within-run (CVs between 1.58 and 6.2%) and between-run (CVs 6.3-11.5%) precision was found. No significant carry-over was observed. A wide linearity of the assay was demonstrated. With the concordance between the clinical history and SPT as the reference value, the clinical sensitivity of the ENEA System was 84.1%, the specificity 82.8%, and the overall efficiency 83.4%. Finally, a good agreement with the results of another technique for the in vitro measurement of specific IgE (Pharmacia CAP System) was proven.