NCT05621876

Evaluation of an IgG Deficiency Rapid Screening Test: A Performance Study With Primary Immunodeficiency (PID) Patients in Tunisia

Evaluation of an IgG Deficiency Rapid Screening Test (RDT) With Human Capillary Samples: A Protocol to Generate RDT Performance Data in Primary Immunodeficiency Patients (PID)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Immunodeficiency Diseases

Interventions

Type	Name	Description
DEVICE	IgG deficiency rapid screening test	We will be testing patients who have already been diagnossed iwth primary immunodeficiency (PID) disease. there are 400 types of PID. We will test their blood before they receive antibody transfusion to evaluate the accuracy of our new screening test. We are trying to develop easy to use, low-cost screening tests for doctors to use with patients to detect those with low IgG levels before they are given the oral polio vaccine. These patients must be prioritized for intramuscular injections of a polio vaccine to prevent potential spread of wild type polio.

Timeline

• Start date: 2024-05-15
• Primary completion: 2024-09-01
• Completion: 2024-09-30
• First posted: 2022-11-18
• Last updated: 2025-07-31

Locations

1 site across 1 country: Tunisia