In vitro diagnostic evaluation of patients with inhalant allergies: summary of probability outcomes comparing results of CLA- and CAP-specific immunoglobulin E test systems.

For the diagnosis of allergy, presence of allergen-specific immunoglobulin E (IgE) usually is established either by allergen skin tests or by in vitro allergen-specific IgE measurements. However, in vitro assays of specific IgE often are modified as manufacturers improve allergens or change reagents to optimize test performance, affecting the diagnostic performance of in vitro allergen-specific IgE assays. This investigation compares the diagnostic outcomes of the Hitachi Chemical Diagnostics chemiluminescent assay (CLA) and Pharmacia, capsulated hydrophilic carrier polymer (CAP) in vitro allergen-specific IgE test methods in patients with inhalant allergy to a panel of selected allergens. Sera were obtained from 60 consecutive patients who had a clinical history suggesting inhalant allergy and were evaluated by allergen skin-prick test (SPT). Only patients with clinical findings of allergic asthma or rhinoconjunctivitis were included. Sera from patients with at least one positive SPT, which clinically correlated with the case history, were used for specific IgE measurements. Sensitivity and specificity were defined as conditional probabilities describing performances of the CAP system and the CLA system in reference to a standard composed of a combination of allergen-specific symptoms and a positive SPT. A test concordance of 79% was found between the CLA and CAP test results with a correlation coefficient of 0.8. Allergen-specific IgE assay sensitivity of the CLA and CAP systems was similar and allergen dependent, ranging from 67 to 100%. Assay specificity ranged from 39 to 86% for the CLA system and from 36 to 81% for the CAP system. When comparing the specific IgE results with allergen SPTs, 75% (+/- 3%) of CLApositive patients had a positive SPT, and 92% (+/- 4%) of CAPpositive patients had a positive SPT. Eighty-four percent (+/- 4%) of CLAnegative patients had a negative SPT, whereas 69% (+/- 5%) of CAPnegative patients had a negative SPT. The overall concordance between skin tests and in vitro tests was 76% for CLA and 67% for CAP. CLA and CAP score values showed good correlation and both tests may be useful when skin tests cannot be performed to identify subjects with IgE-mediated allergy. The CLA and CAP assays for allergen-specific IgE may be useful as part of an initial allergy evaluation because of the high negative predictive value of negative test results. For the majority of allergens the sensitivity was high. However, the specificity of both in vitro tests was low, indicating that positive in vitro test results should be evaluated carefully in conjunction with clinical symptoms and allergen-specific skin tests to determine the clinical relevance of the allergen sensitization.