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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atopic Asthma

Intervention / Treatment
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* Procedure: Blood sample
* Device: POCT device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Capillary Blood Sampling<br>Capillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples | Procedure: Blood sample<br>* Fingerprick and venous<br>Device: POCT device<br>* Investigational device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0 or Day 1 (Visit 2: Blood sampling) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device usability questionnaire response | Device usability assessment of the POCT device as per operators at the completion of the study. | Day 0 or Day 1 (Visit 2: Blood sampling) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total IgE measurement, Novel Point-of-care test device, atopic conditions, in vitro diagnostic test