Clinical validation of the NOVEOS immunoassay for allergy diagnostics

• Conditions: Allergy; hypersensitivity; 10001708

• Registration Number: NL-OMON51863
• Lead Sponsor: Reinier de Graaf Groep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 326

Inclusion Criteria

Age > 3 years
Suspected food allergy to peanut, cow's milk, chicken egg, nuts, sesame seeds,
cod and/or wheat.

Exclusion Criteria

Use of anti-IgE injections (Xolair), systemic corticosteroids, or
anti-histamines (which should be discontinued three days before performing a
skin prik test).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>sIgE against 12 allergens is determined on the NOVEOS system and compared with<br /><br>the results of the skin prick tests, the clinical diagnosis and sIgE<br /><br>measurements on the standard method (Siemens Immulite).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>There will be investigated whether the use of biotin supplements leads to<br /><br>different results on the NOVEOS compared to the Immulite.<br /><br>In addition, it will be investigated whether there is less interference of sIgE<br /><br>against CCDs on the NOVEOS.</p><br>