Clinical validation of ImmuneCheck IgE for the rapid detection of serum total IgE

ABSTRACT

PURPOSE: Conventional serum IgE assay was costly, required the skills of expert, and relied heavily on expensive equipment. Quantitative measurement of total IgE using Point of Care Test (POCT) device can be the solution for these limitations. This study evaluated and validated the reproducibility of ImmuneCheck IgE. METHODS: This study included 120 patients of allergic diseases such as allergic rhinitis, asthma, drug allergy, food allergy, atopic dermatitis, or anaphylaxis . The reliability of POCT ImmuneCheck IgE was evaluated by comparing results from the naked eye and from the Q-Reader. Intratest reproducibility and intertest correlation were analyzed using intraclass correlation coefficient (ICC). RESULTS: Of the 120 enrolled patients, 51 were males and 69 were females. The ages ranged from 19 to 84 years, with an average age of 51.5 years. The concentration of serum total IgE measured by Phadia ImmunoCAP IgE ranged from 5.95 to 5,000 IU/mL. ICC for Intratest reproducibility of ImmuneCheck IgE by naked eye and by Q-Reader were 0.991 (P < 0.001) and 0.989 (P < 0.001), respectively. In addition, intertest correlation between ImmuneCheck IgE and Phadia ImmunoCAP IgE results of naked eye and Q-Reader were 0.968 (P < 0.001) and 0.948 (P < 0.001), respectively. CONCLUSION: The ImmuneCheck IgE was reproducible and highly correlated with conventional Phadia ImmunoCAP IgE assay. This result suggests that ImmuneCheck IgE can be a useful tool for rapid and precise detection of total IgE.