CompletedNot Applicable

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

Tunisia50 participantsStarted 2024-05-15

Plain-language 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.

Who can participate

Age range6 Months – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: \-

What they're measuring

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.

Timeframe: 3 month

To evaluate % agreement between the PID RDT(using capillary blood)and the referent test (serum/plasma).

Timeframe: 3 months

Trial details

NCT IDNCT05621876

SponsorPATH

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-01

View on ClinicalTrials.gov More Primary Immunodeficiency Diseases trials