Primary Immunodeficiency DiseasesNCT05621876
Evaluation of an IgG Deficiency Rapid Screening Test: A Performance Study With Primary Immunodeficiency (PID) Patients in Tunisia
An observational study of Primary Immunodeficiency Diseases, run by PATH at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Primary Immunodeficiency Diseases
- What is being tested?
- IgG deficiency rapid screening test
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 50 participants
- Where
- 1 siteTunisia
- Study dates
- 15 May 2024to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: PID patients prior to receiving IV-Ig treatment infusions for the first time or during follow-up at the NBMT center in Tunis. The day of their monthly infusion, they are expected to have the lowest residual IgG level. These patients have previously been identified with AG, HAG, CVID and HIGM and this is why they are receiving IV-Ig therapy at NBMT. Patients will be 6 months of age or older and the patient or guardian must give consent for participation.
Who may be able to join
- 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).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Primary Immunodeficiency Diseases
- Being tested
- IgG deficiency rapid screening test
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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?
Measured: 3 months
Secondary outcomes (2)
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?
Measured: 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?
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start15 May 2024
- Primary completion1 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Institut Pasteur de Tunis, Centre National de Greffe de Moelle Osseuse
- Responsible party
- Principal investigator, Megan Parker, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621876
- Sponsor's protocol ID
- 1923231
- Status last verified
- Jul 2025
- First submitted
- 10 Nov 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Knowledge gained from this study may benefit society by providing information on the diagnostic accuracy of the first PID RDT. Data obtained from this study will be made available to the test manufacturer to support their product dossier, and ultimately to provide countries still working to eradicate polio with quality-assured PID RDTs with analytical and clinical performance beyond that provided by the Jeffrey Modell warning signs.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05621876
- Acronym / sponsor ID
- 1923231
- Conditions
- Primary Immunodeficiency Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Institut Pasteur de Tunis, Centre National de Greffe de Moelle Osseuse
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- PID patients prior to receiving IV-Ig treatment infusions for the first time or during follow-up at the NBMT center in Tunis. The day of their monthly infusion, they are expected to have the lowest residual IgG level. These patients have previously been identified with AG, HAG, CVID and HIGM and this is why they are receiving IV-Ig therapy at NBMT. Patients will be 6 months of age or older and the patient or guardian must give consent for participation.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IgG deficiency rapid screening testWe 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. | Device | – |
Primary outcome
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.
Time frame: 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).
Time frame: 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?
2 secondary outcomes
To determinethe utility of the PID RDTwith PID patients.
Time frame: 3 months
To determine% agreement between capillary and venous blood samples using the PID RDT
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Undecided. Knowledge gained from this study may benefit society by providing information on the diagnostic accuracy of the first PID RDT. Data obtained from this study will be made available to the test manufacturer to support their product dossier, and ultimately to provide countries still working to eradicate polio with quality-assured PID RDTs with analytical and clinical performance beyond that provided by the Jeffrey Modell warning signs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immunodeficiency Diseases, run by PATH at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.