Evaluation of the Immunoglobulin-G-Dried Blot Spot (IgG-DBS) diagnostic tool kit compared to the standard method for monitoring serum IgG levels

• Conditions: D80; D84; Immunodeficiency with predominantly antibody defects; Other immunodeficiencies

• Registration Number: DRKS00020522
• Lead Sponsor: niversitätsklinikum Freiburg, Institut für Immundefizienz & Centrum für Chronische Immundefizienz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-28
• Study Completion: 2021-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 150

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

- Participation in any interventional clinical study within the last 30 days
- Patient does not receive Ig substitution treatment (IV or SC)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.