Evaluation of a novel point-of-care test for the rapid semi-quantitative detection of allergen-specific immunoglobulin E

Abstract

ABSTRACTBackground: Allergen-specific IgE levels in human sera support the diagnosis of allergies. However, commonly used laboratory tests are time consuming. The new point-of-care test FastCheckPOC 20 (FCP20) allows the simultaneous and semi-quantitative evaluation of IgE antibodies for 20 aeroallergens and food allergens.Methods: Two hundred patients with allergic symptoms were included in a multicenter performance evaluation using both whole blood and plasma or serum samples. FCP20 results were compared with the skin prick test (SPT) and the ImmunoCAP system (Phadia) which was used as reference for specific IgE values.Results: The concordance between FCP20 and ImmunoCAP was 76% for positive results and 80% for negative results over 20 allergens. Overall agreement (accuracy) of FCP20 with the ImmunoCAP was 80% across all 20 allergens. The concordance between FCP20 and SPT over all 20 allergens was 66% for positive results and 71% for negative results. Overall agreement of FCP20 with the SPT was 70%. Semi-quantitative FCP20 results (Levels 1–5) revealed nearly identical values for whole blood and plasma/serum test results. A good concordance was also observed between FCP20 levels and ImmunoCAP classes.Conclusions: FastCheckPOC 20 is reliable to determine allergen-specific IgE in human whole blood and plasma/serum samples.