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

PATH50 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Primary Immunodeficiency Diseases

Interventions

IgG deficiency rapid screening testDEVICE

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

Sex: ALLMin age: 6 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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: \-

Locations (1)

National Bone Marrow Transplant center

Tunis, Tunisia

Outcomes

Primary Outcomes

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?

Time frame: 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?

Time frame: 3 months

Secondary Outcomes

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?

Time frame: 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?

Time frame: 3 months

Data from ClinicalTrials.gov

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