Background: The flow cytometry CD63-based basophil activation test (Basotest®) has already been validated for the diagnosis of immediate-type allergy such as venom, house dust mite or cypress pollen allergies. The aim of this study was to evaluate the performance (specificity and sensitivity) of Basotest in the diagnosis of natural rubber latex allergy. Methods: We included 46 latex allergic patients (clinical symptoms of latex allergy, positive latex skin prick tests and/or latex specific IgE) and 33 control subjects and performed Basotest on all subjects. Results: The sensitivity and specificity of Basotest were 84.8 and 87.9%, respectively, when we considered the theoretic cut-off at 15% of CD63-positive cells. Using ROC curves, the optimal cut-off was evaluated at 22%, for which sensitivity and specificity were 79.3 and 96.7%, respectively. Conclusion: The Basotest is a reliable test in addition to clinical history and tests already validated (such as skin prick tests and specific IgE) to confirm the diagnosis of natural rubber latex allergy.
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