Performance characteristics of a new automated enzyme immunoassay for the measurement of allergen-specific IgE : Summary of the probability outcomes comparing results of allergen skin testing to results obtained with the HYTEC system and CAP system

摘要: Background Measurement of allergen-specific IgE may assist in the diagnosis allergy selected patients. The development new assays for determination should be optimized with respect to analytical sensitivity, precision, automation, and reporting test results mass units. Objective objectives this study were evaluate performance automated HYTEC method measurement compare assay that Pharmacia CAP system. Methods To demonstrate parallelism, dilution curves generated by diluting four patient sera containing cat (19.8 kU/L), D. pteronyssinus (5.4 birch pollen (2.6kU/L), timothy grass (1.0kU/L) equine serum. precision utilized from three different atopic donors low levels (0.62 ± 0.05 moderate (1.45 0.18 high (13.59 0.89 kU/L) common inhalant allergens: , grass, birch. Sera outcome probability determinations obtained 54 patients who evaluated presence skin prick physical examination. Only at least one positive clinically correlated physician's evaluation case history examination material. In study, sensitivity specificity are conditional probabilities describing performances system testing. lowest threshold, 0.35 kU/L, recommended detection IgE, was used both systems. Results accurately detected a reduction antibody serum concentrations ranging 0.10 kU/L 20 kU/L. median interdilutional coefficient variation 12.5% samples 19.8 0.1 antibody. During 20-day trial period, standard controls, 0.62, 1.45, 13.39 respectively, demonstrated mean less 18%. 20% patients, duplicate measurements resulted one-class discrepancy range, 0.70 only. correlation between 0.77, rank coefficients, being allergen-dependent 0.62 0.91. Allergen-specific ranged 0.78 1.00, whereas 0.50 1.00. Assay 0.66 0.93 0.87 Eighty-nine percent HYTEC-positive had (3% error) 87% CAP-positive (4% error). Ninety-two HYTEC-negative negative error), 76% CAP-negative (5% Conclusion fulfills current requirements necessary measure quantitatively qualitatively, compares favorably