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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
193
Fingerprick and venous
Investigational device
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Lübeck, Germany
Novartis Investigative Site
Padova, PD, Italy
Total IgE concentration
Total IgE concentration in capillary blood measured with the POCT device at Day 0 or Day 1 from enrollment. Total IgE concentration in venous blood measured with the reference method at Day 0 or Day 1 from enrollment.
Time frame: Day 0 or Day 1 (Visit 2: Blood sampling)
Device usability questionnaire response
Device usability assessment of the POCT device as per operators at the completion of the study.
Time frame: Day 0 or Day 1 (Visit 2: Blood sampling)
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Novartis Investigative Site
Pisa, PI, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Harderwijk, Netherlands, Netherlands
Novartis Investigative Site
Almelo, Netherlands
Novartis Investigative Site
Sabadell, Barcelona, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Chertsey, Surrey, United Kingdom
...and 2 more locations