Flow Cytometry-Assisted Basophil Activation Test as a Safe Diagnostic Tool for Aspirin/NSAID Hypersenstivity

PURPOSE: Aspirin and non-steroidal anti-inflammatory drugs (ASA/NSAIDs) are common causes of drug hypersensitivity. An oral provocation test is the only definitive diagnostic test. This study assessed the reliability of a flow cytometry-assisted basophil activation test (FAST) as a safe diagnostic method for ASA/NSAID-induced hypersensitivity, as its high sensitivity and specificity have been demonstrated for many other drugs. METHODS: Eighteen patients and 11 controls were enrolled. Using a Flow-CAST kit® (Bühlmann Laboratories AG, Schönenbuch, Switzerland), 29 analyses with aspirin, ibuprofen, and diclofenac were performed by flow cytometry to detect double-positive staining of anti-IgE and anti-CD63. The stimulation index was defined as the activated basophil percentage after drug stimulation/basally active basophil percentage. A stimulation index≥2 and an absolute activated basophil percentage≥5 were considered positive. RESULTS: Patients with hypersensitivity to ASA/NSAIDs were predominantly female, and the prevalence of atopy was higher in patients than in controls. A sensitivity of 61%, specificity of 91%, positive predictive value of 92%, and negative predictive value of 59% were achieved. CONCLUSIONS: FAST is a useful additional method for diagnosis of hypersensitivity reactions to ASA/NSAIDs. Further development is required to increase the sensitivity of the test.