Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic Subjects

A Multicenter Clinical Evaluation Study to Determine the External Site Accuracy of Total Immunoglobulin E Measurement Using a Novel Point of Care Test Device Compared to a Reference Method in Atopic Subjects

The purpose of this study is to determine the accuracy of the Novel point of care test (POCT) total IgE assay in atopic patients.

120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled. Fingerstick capillary blood samples will be collected and tested in the POCT device. Venous samples will be collected and sent to a reference laboratory for measurement of serum total IgE using the reference immunoassay method.

Inclusion criteria: atopic patients

• Subjects who are diagnosed with atopic condition
• Subjects or legal guardians who are able to give informed consent
• Other protocol-defined inclusion criteria may apply Exclusion criteria: atopic patients
• Subjects who have received anti-IgE antibody treatment
• Subjects who have elevated IgE levels for reasons other than allergic conditions
• Other protocol-defined exclusion criteria may apply Inclusion criteria: healthy subjects
• Subjects who are able to give informed consent for participation in the study according to local requirements / law.

Exclusion criteria: healthy subjects

• Subjects who have received anti-IgE antibody treatment
• Subjects with a suspected or confirmed clinical diagnosis of an atopic condition
• Other protocol-defined exclusion criteria may apply