Evaluation of an IgG Deficiency Rapid Screening Test: A Performance Study With Primary Immunodeficiency (PID) Patients in Tunisia
Launched by PATH · Nov 10, 2022
Trial Information
Current as of July 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new test designed to quickly check for a condition called IgG deficiency in patients who have primary immunodeficiency diseases (PID). The researchers want to see how well this test works compared to standard lab tests and whether it can be used with small blood samples taken from a finger prick, as opposed to larger samples taken from a vein. The goal is to improve how we screen for PID, which can help patients get the right treatment more efficiently.
To participate in this study, individuals need to be at least 6 months old and diagnosed with certain types of PID that require monthly treatment with intravenous immunoglobulin (IV-Ig). This includes conditions like agammaglobulinemia and common variable immunodeficiency. The trial is not currently recruiting participants, but when it does begin, those who qualify can expect to have their blood tested using both the new method and the standard method to see how well they match. This could lead to better and faster care for patients with these immune system issues.
Gender
ALL
Eligibility criteria
- 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:
- • -
About Path
Path is a leading global non-profit organization dedicated to improving public health by developing and implementing innovative solutions to health challenges. With a focus on enhancing healthcare access and equity, Path collaborates with governments, NGOs, and private sector partners to design and deliver effective interventions and technologies. The organization specializes in areas such as infectious diseases, maternal and child health, and vaccine development, leveraging research and data to inform evidence-based practices. Through its commitment to advancing health systems and empowering communities, Path strives to create sustainable health improvements for populations worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tunis, , Tunisia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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