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

Novartis

Status and phase

Completed

Phase 2

Conditions

Atopic Asthma

Treatments

Device: POCT device

Procedure: Blood sample

Study type

Interventional

Funder types

Industry

Identifiers

NCT02758548

CDIGE0012201

Details and patient eligibility

About

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.

Enrollment

193 patients

Sex

All

Ages

6+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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