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

Primary Immunodeficiency Diseases Clinical Trial

Official 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05621876
• Other study ID #: 1923231
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: PATH
• Contact: Megan Parker
• Phone: 202.460.6239
• Email: mparker[@]path.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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: -

Related Conditions & MeSH terms

• IgG Deficiency
• Immunologic Deficiency Syndromes
• Primary Immunodeficiency Diseases

Intervention

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.

Locations

Country	Name	City	State
Tunisia	National Bone Marrow Transplant center	Tunis

Sponsors (4)

Lead Sponsor	Collaborator
PATH	Bill and Melinda Gates Foundation, Centre National de Greffe de Moelle Osseuse, Institut Pasteur de Tunis

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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