High-throughput serology platform for antibody testing
Official title: Development of a High-throughput Serological Testing Platform for Mass Screening Purposes of Both Pediatric and Adult Cohorts
Run by Istituto Zooprofilattico Sperimentale delle Venezie · NCT06939556 · Data updated 2026-11-12
This project will test whether a 384-format high-throughput neutralization assay combined with finger-prick Mitra VAMS microsampling gives comparable antibody results to standard blood draws in adults (20–65) and children (2–10).
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 65 Years |
| Sex | All |
| Enrollment | 152 (estimated) |
| Sponsor | Istituto Zooprofilattico Sperimentale delle Venezie Academic / other |
| Locations | 2 sites (Padova, Italy and 1 other locations) |
| Status | Recruiting |
| Started | April 15, 2025 |
| Main results expected | July 30, 2025 |
| Study ends | October 31, 2025 |
| Registry record updated | June 8, 2025 |
| Trial ID | NCT06939556 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults aged 20–65 and children aged 2–10 who can provide informed consent (or have caregiver consent) and do not have immunocompromising conditions, chronic inflammatory diseases, or recent immunomodulatory treatment.
✕Probably not a fit
Patients who are immunocompromised, have chronic inflammatory or autoimmune conditions, or received immunomodulatory therapy in the past year (and people outside the specified age ranges) are unlikely to be eligible or to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The project develops a 384-format neutralization assay to enable high-throughput serological testing for emerging and re-emerging respiratory and other high-priority viruses. It validates Mitra volumetric absorptive microsampling (VAMS) finger-prick devices by comparing paired adult and pediatric samples collected by venipuncture and by microsampling. The platform will be tested using antibodies against endemic viruses such as influenza A and extended to families of concern (Orthomyxoviridae, Coronaviridae, Flaviviridae) to increase regional and national preparedness. The goal is to streamline sampling and laboratory throughput for large emergency serosurveys.
Why it matters
Potential benefit: If successful, this approach could make large-scale antibody screening faster and easier by allowing reliable finger-prick collection and high-throughput neutralization testing, improving pandemic response capacity.
How similar studies have gone: Previous work comparing Mitra VAMS microsampling to venous blood and deploying high-throughput serology has shown promising concordance, though applying a 384-format neutralization assay across multiple high-priority viral families is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Adult Cohort - between 20 and 65 years of age Pediatric Cohort - between 2 and 10 years of age Signed consent form by the subject for adults or by caregivers for children Exclusion Criteria: 1. subjects with an immunocompromised status, such as immunodeficiency disorders or those undergoing immunosuppressant treatments 2. subjects with underlying chronic inflammatory conditions (i.e., autoimmune disorders, chronic gastrointestinal, and rheumatic conditions) 3. subjects who have received immunomodulatory treatment within the past year.
Where it's running
-
Istituto Zooprofilattico Sperimentale delle Venezie
Padova, Italy, Italy Recruiting -
Padova University Hospital, Department of Women's and Children's Health
Padova, Italy, Italy Recruiting
Study contacts
- Study coordinator: Head of the Laboratory of Experimental Animal Models IZSVe
- Email: fbonfante@izsvenezie.it
- Phone: +39 049 8084101-102
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.