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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02758548

Enrollment

193

Registered

2016-05-02

Start date

2016-03-31

Completion date

2016-05-31

Last updated

2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Asthma

Keywords

Total IgE measurement, Novel Point-of-care test device, atopic conditions, in vitro diagnostic test

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.

Interventions

PROCEDUREBlood sample

Fingerprick and venous

DEVICEPOCT device

Investigational device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Germany, Italy, Netherlands, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026