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NCT05621876
Evaluation of an IgG Deficiency Rapid Screening Test: A Performance Study With Primary Immunodeficiency (PID) Patients in Tunisia
Conditions: Primary Immunodeficiency Diseases
Sex: All
Ages: 6 Months – 18 Years
Enrollment: 50
Sponsor: PATH
Location: Tunisia
Summary
To evaluate the usability and utility of the device, % agreement between the PID-RDT and the referent assay (serum/plasma), and % agreement between capillary blood and venous blood samples using the PID-RDT within confirmed PID patients prior to receipt of their monthly IV-Ig treatment.
Eligibility Criteria
Inclusion Criteria:Must be 6 months of age.The types of PID presenting for IV-Ig therapy will include Evaluation of PID RDT with human capillary blood (version 1.0) | 8agammaglobulinemia (AG), hypogammaglobulinemia (HAG), common variable immunodeficiency (CVID), and hyper IgM syndrome (HIGM).Exclusion Criteria:-
Source: ClinicalTrials.gov (NCT05621876). StuddyBuddy aggregates publicly available trial information.
