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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05621876

Enrollment

Registered

2022-11-18

Start date

2024-05-15

Completion date

2024-09-30

Last updated

2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immunodeficiency Diseases

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.

Interventions

DEVICEIgG 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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?

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026