Accuracy total Immunoglobulin Test 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
180004
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
Novartis Pharma Services AG
Duration of Study in the UK
0 years, 2 months, 13 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 PointofCare Test (POCT) device. The assay will be used to aid with the diagnosis and clinical management of participants with atopic conditions. The purpose of this study is to determine the accuracy of the point of care IgE assay in atopic participants and healthy subjects. The POCT results will be compared to a reference immunoassay method for measuring this analyte.
Globally approximately 120 participants 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. In the UK 30 adult participants with atopic conditions and 20 healthy volunteers will be enrolled - no children will be enrolled in the UK.
Globally, (for those countries enroling children) participants will be stratified into two age groups (6-17years old and ≥18years old). Participants ≥18years old will also be stratified based on screening total IgE level.
Fingerprick 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
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
15/YH/0214
Date of REC Opinion
28 Jul 2015
REC opinion
Further Information Favourable Opinion