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Completed

NCT Number: NCT05621876

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

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.

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Key information

Conditions

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

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Bone Marrow Transplant center

Tunis, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Primary outcomes

  1. 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.

    Time frame: 3 month

    • 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?

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

    Time frame: 3 months

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

Secondary outcomes

  1. To determinethe utility of the PID RDTwith PID patients.

    Time frame: 3 months

    Can the investigational PID RDT be used with a finger prick (capillary) blood sample among study participants?

    • Was the finger prick blood sample successfully collected from the finger and transferred to the PID RDT?•Did the test run complete and give a valid result when run according to instructions?
    • Could a result be interpreted from the PID RDT?

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

    Time frame: 3 months

    What is the % agreement between fresh capillary blood and fresh venous blood using the PID RDT?

Sponsors and collaborators

Lead sponsor

PATH

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Centre National de Greffe de Moelle Osseuse
  • Institut Pasteur de Tunis

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2022
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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