BACKGROUND: Allergen specific IgE (sIgE) assay is an important aid in the diagnosis and treatment of allergy. We evaluated the analytical performance of a quantitative chemiluminescence immunoassay for sIgE using the continuous random access ADVIA Centaur. METHODS: Six ADVIA Centaur sIgE reagents for common inhalant allergens in Korea, d1, d2, e1, e5, t3, and t7, were evaluated for precision, dilution recovery (parallelism), comparison with Pharmacia UniCAP sIgE assay and skin prick test, sample volume, and analytical speed according to the NCCLS guidelines (I/LA20-A, EP5-A2). Commercialized positive and negative quality control materials were used for a precision study, and samples from a total of 110 patients were used for dilution recovery and comparison studies. RESULTS: Within-run coefficients of variation (CV) of the 6 items were 3.45-6.14% and within-device CVs (total CVs) of all items were below 10%. Interdilutional CVs of all items were 2.84-11.95%, which showed a good linearity and parallelism over its measuring range. Positive/negative concordance rates of the 6 items with UniCAP sIgE assay were 76.3-96.1% (d1, 88.2%; d2, 96.1%; e1, 91.0%; e5, 77.0%; t3, 90.5%; and t7, 76.3%). Concordance rates of the six items with skin prick test were all above 80%. The quantity of sample volume (25 micro L/test) needed was relatively small, and a high throughput (120 tests/hr) and rapid turnaround time (47 min) could be achieved. CONCLUSIONS: The ADVIA Centaur sIgE assay was thought to be a convenient and efficient method to be used in medium- to large-sized laboratories.
Allergens ; Diagnosis ; Humans ; Hypersensitivity ; Immunoassay* ; Immunoglobulin E* ; Indicators and Reagents ; Korea ; Luminescence ; Quality Control ; Skin