Collection of blood samples for analytical performance evaluation under the IVDR of in vitro test systems in the area of Allergy and Nutrition Care
- Conditions
- AllergiesFood Intolerance
- Registration Number
- DRKS00024808
- Lead Sponsor
- R-Biopharm AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
1. ability to understand and willingness to sign a written consent form.
2. females and males 18 years of age or older.
3. Presence of allergy(s) and/or food intolerance(s) (self-reported).
4. collection of the required volume of whole blood and capillary blood possible.
5. min. 50 kg body weight (in case of allergy).
Exclusion Criteria
6. pregnant and lactating women
7. anemia
8. increased bleeding tendency, or known blood clotting disorder
9. intake of immunosuppressants
10. intake of Omalizumab
11. an event due to which, in the opinion of the principal investigator, the subject is not suitable for participation in the study.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of the study is the recruitment of a maximum of 300 subjects with allergy and/or food intolerance.
- Secondary Outcome Measures
Name Time Method Secondary outcome is finding individuals with a rare allergen (e.g., baker's yeast, dandelion, or cocoa).