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

Not yet recruiting

• Conditions: Primary Immunodeficiency Diseases

• Registration Number: NCT05621876
• Lead Sponsor: PATH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Study Start: 2024-05-15
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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?
To evaluate % agreement between the PID RDT(using capillary blood)and the referent test (serum/plasma).	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 Outcome Measures

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

Trial Locations

Locations (1)

National Bone Marrow Transplant center; 🇹🇳 Tunis, Tunisia