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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Immunodeficiency Diseases
• Intervention / Treatment: Device: IgG deficiency rapid screening test

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Megan Parker; Phone Number: 202.460.6239; Email: mparker@path.org

Study Locations

• Tunisia
  • Tunis, Tunisia
    • National Bone Marrow Transplant center
    • Contact: Monia Ouederni, MD; Email: monia.ouederni@fmt.utm.tn
    • Contact: Ilhem Ben Fredj, MD; Email: befraj-ilhem@live.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determinethe utility of the PID RDTwith PID patients.	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?	3 months
To determine% agreement between capillary and venous blood samples using the PID RDT	What is the % agreement between fresh capillary blood and fresh venous blood using the PID RDT?	3 months

Collaborators and Investigators

• Sponsor: PATH
• Collaborators: Bill and Melinda Gates Foundation; Centre National de Greffe de Moelle Osseuse; Institut Pasteur de Tunis

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hematologic Diseases; Genetic Diseases, Inborn; Blood Protein Disorders; Dysgammaglobulinemia; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases; IgG Deficiency
• Other Study ID Numbers: 1923231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Knowledge gained from this study may benefit society by providing information on the diagnostic accuracy of the first PID RDT. Data obtained from this study will be made available to the test manufacturer to support their product dossier, and ultimately to provide countries still working to eradicate polio with quality-assured PID RDTs with analytical and clinical performance beyond that provided by the Jeffrey Modell warning signs.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No