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

NCT05621876 | Completed

• 1 other identifier: 1923231
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• To evaluateusability among end users of the PID rapid screening tests using capillary blood samples obtained from PID patients, prior to receipt of IV-Ig treatment.

  \- Did the test run correctly when following the IFU? •Was the end user (nurse) able to interpret a test result for the patient from the investigational PID RDT (positive, negative) with valid control using a patient's capillary finger prick sample?

  3 month

• To evaluate % agreement between the PID RDT(using capillary blood)and the referent test (serum/plasma).

  What is the % agreement between the PID RDT run on capillary blood (Capillary Test A) and the referent assay run on plasma/serum?

  3 months

Secondary Outcomes (2)

• To determinethe utility of the PID RDTwith PID patients.

  3 months

• To determine% agreement between capillary and venous blood samples using the PID RDT

  3 months

Interventions

IgG deficiency rapid screening test DEVICE

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.

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

PID patients prior to receiving IV-Ig treatment infusions for the first time or during follow-up at the NBMT center in Tunis. The day of their monthly infusion, they are expected to have the lowest residual IgG level. These patients have previously been identified with AG, HAG, CVID and HIGM and this is why they are receiving IV-Ig therapy at NBMT. Patients will be 6 months of age or older and the patient or guardian must give consent for participation.

You may qualify if:

• 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).

Sponsors & Collaborators

• PATH: lead
• Bill and Melinda Gates Foundation: collaborator
• Institut Pasteur de Tunis: collaborator
• Centre National de Greffe de Moelle Osseuse: collaborator

Study Sites (1)

National Bone Marrow Transplant center

Tunis, Tunisia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will be retaining small amounts of plasma to be held at IPT in Tunisia for future testing. We are asking study participants if they want to contribute samples to the biorepository. No samples will be obtained without their consent. These samples will be de-identified, and only be labelled with the type of PID the child experiences. There are 400 different types of primary immunodeficiencies and we are trying to improve low-cost diagnostics to detect all types to detect low IgG individuals to prevent the spread of polio from the polio vaccine.

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Program Officer

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 18, 2022
• Study Start: May 15, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 30, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

TU (1)