Novel Application of Immunochromatographic Assay for Measurement of Total Tear Immunoglobulin E

PURPOSE: The aim of this study was to evaluate the efficacy of a new immunochromatographic assay (Aifeice) in the diagnosis of allergic conjunctivitis diseases (ACDs) and to explore the relationship between Aifeice testing results and the severity of ACDs. METHODS: A multicenter prospective cross-sectional study (390 patients diagnosed with ACDs and 619 healthy controls) was conducted. Patients with ACDs were scored based on clinical symptoms. All participants received the Aifeice test. The positive testing results were further divided into 3 immunoglobulin E (IgE) grades. Statistical analysis was performed to evaluate the indexes associated with the testing results. RESULTS: The sensitivity, specificity, positive predictive value, negative predictive value, and total coincidence rate of the Aifeice test were 96.15%, 98.87%, 98.17%, 97.61%, and 97.82%, respectively. The total clinical score was significantly correlated with the IgE grade. The factors that affected the IgE score were conjunctival hyperemia, conjunctival swelling, conjunctival papillae, and Horner–Trantas dots. CONCLUSIONS: The high sensitivity and specificity of Aifeice in the diagnosis of ACD was confirmed. This new immunochromatographic assay could be used to assess the severity of ACD.