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Collection of blood samples for analytical performance evaluation under the IVDR of in vitro test systems in the area of Allergy and Nutrition Care

Collection of blood samples for analytical performance evaluation under the IVDR of in vitro test systems in the area of Allergy and Nutrition Care - IVDR-All/NC-01

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00024808
Enrollment
300
Registered
2021-08-27
Start date
2021-08-24
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Allergies Food Intolerance

Interventions

Group 1: Both a serum and a capillary blood sample will be collected from all subjects. Based on these samples, the sponsor decides whether the subjects will be invited for a second blood draw. In thi

Sponsors

R-Biopharm AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is the recruitment of a maximum of 300 subjects with allergy and/or food intolerance.

Secondary

MeasureTime frame
Secondary outcome is finding individuals with a "rare" allergen (e.g., baker's yeast, dandelion, or cocoa).

Countries

Germany

Contacts

Public ContactMichael Kramer

Praxis für Laboratoriumsmedizin

nahrung-allergie@praxis-dr-kramer-hd.de06157 – 9863173

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026