D80 D84
Conditions
Interventions
Group 1: Patients with primary immunodeficiency on immunoglobulin replacement therapy - IgG trough levels in comparison between serum, DBS (with/without shipping)
Sponsors
Universitätsklinikum Freiburg, Institut für Immundefizienz & Centrum für Chronische Immundefizienz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patient is diagnosed having PID - Patient planned to get an IV blood drawing for serum Ig level determination at a regular hospital visit - Patient receives Ig substitution treatment (IV or SC) - Patient is able to perform a finger prick and the DBS spotting either independently after instruction or with support of medical staff
Exclusion criteria
Exclusion criteria: - Participation in any interventional clinical study within the last 30 days - Patient does not receive Ig substitution treatment (IV or SC)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the suitability of the IgG-DBS test kit (immunoglobulin G dry blood card assay kit) for monitoring IgG serum levels in patients with PID in comparison to the standard IV method by correlating the IgG level in DBS eluates with those in the serum. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the impact of DBS sample shipping on the performance of the IgG-DBS test kit for monitoring IgG blood levels in patients with PID and evaluation of the differences in the rate of analyzable samples between DBS cards without shipping, DBS cards with shipping and the standard method. | — |
Countries
Germany
Contacts
Public ContactBodo Grimbacher
Universitätsklinikum Freiburg, Institut für Immundefizienz & Centrum für Chronische Immundefizienz
Outcome results
None listed