SPECIFIC IGE ANTIBODIES IN THE DIAGNOSIS OF ATOPIC DISEASE - CLINICAL-EVALUATION OF A NEW IN-VITRO TEST SYSTEM, UNICAP(TM), IN 6 EUROPEAN ALLERGY CLINICS

A new immunoassay system utilizing new automatic instrumentation, new software for evaluation of data, and reagents updated for increased sp eed and accuracy was evaluated. Six clinical studies included 894 cons ecutive patients. Major symptoms were rhinoconjunctivitis, asthma, ato pic dermatitis, and urticaria. The prevalence of inhalant allergy was 54-69%. Phadiatop(R), detecting atopic sensitization to common inhalan t allergens, agreed with clinical diagnosis in 764/836 cases (91.4%). The clinical sensitivity and specificity were 93% and 89%, respectivel y. The clinical sensitivity and specificity of UniCAP specific IgE der ived from 5170 comparisons with clinical diagnosis were 89% and 91%, r espectively. Specific IgE measurements in UniCAP and in the Pharmacia CAP System agreed in 266/274 cases (97%). A comparison of the sensitiv ity and specificity of Pharmacia CAP System RAST in 1987 and with UniC AP specific IgE in 1995 showed equivalent performance without change o f efficacy or degradation of IgE antibodies after 8 years. The systems were equivalent also in terms of measured values (r=0.96, slope=1.12) , confirming the standardization of allergens and of assay calibration . UniCAP is an efficient laboratory system for routine diagnostic test ing of allergy and a valuable tool for basic studies on allergens and antibodies.