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

Phase 2

Completed

• Conditions: Atopic Asthma
• Interventions: Procedure: Blood sample; Device: POCT device

• Registration Number: NCT02758548
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-04-28
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Posted: 2016-05-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-13
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capillary Blood Sampling	POCT device	Capillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples
Capillary Blood Sampling	Blood sample	Capillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples

Primary Outcome Measures

Name	Time	Method
Total IgE concentration	Day 0 or Day 1 (Visit 2: Blood sampling)	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.

Secondary Outcome Measures

Name	Time	Method
Device usability questionnaire response	Day 0 or Day 1 (Visit 2: Blood sampling)	Device usability assessment of the POCT device as per operators at the completion of the study.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Manchester, United Kingdom