Laboratory evaluation of a commercial immunoassay for fire ant allergen-specific IgE antibodies

Background: In vitro testing for fire ant sensitization would be useful for research purposes and in special clinical situations. Methods: Laboratory performance of a commercial assay (Pharmacia CAP System, [PCS]), for specific IgE to Solenopsis invicta whole body extract was studied in 46 persons. Assay results were compared with those of venom skin testing, RAST, and ELISA. The manufacturer's global cutoffs were compared with cutoffs set by using methods derived from analytical detection limit theory. Results: Thirty-two study subjects had positive skin test results, and 14 had negative results. Raw PCS data demonstrated a high level of correlation with RAST (ρ = 0.941) and ELISA (ρ = 0.931), and showed good correlation with skin testing (ρ = -0.769). Analysis of binormal receiver operating characteristic curves, using skin test results as the reference standard, demonstrated no difference in performance among the three assays. The fixed global quantitative cutoff of 0.35 kUa/L was relatively insensitive. Use of the manufacturer's qualitative alternate scoring method cutoff substantially increased sensitivity without loss of specificity, as did lower limit of detection set by use of diluent. Conclusions: In situations in which skin testing for fire ant sensitization is not feasible, PCS appears to be an acceptable in vitro alternative method for determination of fire ant allergen-specific IgE. (J ALLERGY CLIN IMMUNOL 1995;96:182-7.).