Accuracy total ImmunoglobulinTest Device
Research type
Research Study
Full title
A Multicentre 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
IRAS ID
177824
Contact name
Lisa Tran
Contact email
Sponsor organisation
Novartis Pharma Services AG
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
Novartis Near Patient Testing (NPT) is developing a new assay to measure whole blood total immunuglobulin type E (IgE) levels using a novel Point-of-Care Test (POCT) device. The assay will be used to aid with the diagnosis and clinical management of patients with atopic conditions. The purpose of this study is to determine the accuracy of the point-of-care IgE assay in atopic patients and healthy subjects. The POCT results will be compared to a reference immunoassay method for measuring this analyte.
Approximately 120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled and will attend for two visits: a screening visit and a blood sampling visit. Patients will be stratified into two age groups (6-17-years old and =18-years old). Patients =18-years old will also be stratified based on screening total IgE level.
Fingerstick capillary blood samples will be collected and tested on the POCT device. Venous samples will be collected and sent to a reference laboratory for measurement of serum total IgE.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0146
Date of REC Opinion
25 Mar 2015
REC opinion
Unfavourable Opinion