High-throughput Serological Testing of Antibodies Platform
In the case of large emergency serosurveys, innovation in the sampling techniques is an often neglected, but relevant aspect to facilitate the enrolment of subjects in both adult and paediatric populations. Further, neutralization assays are the first line of response immediately after the emergence of a novel virus in
| Condition(s) | Diagnostics, Pandemic Response |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | In the case of large emergency serosurveys, innovation in the sampling techniques is an often neglected, but relevant aspect to facilitate the enrolment of subjects in both adult and paediatric populations. Further, neutralization assays are the first line of response immediately after the emergence of a novel virus in the human population. This study aims at developing at IZSVe 384-format high-throughput neutralization assays for emerging and re-emerging respiratory viruses with pandemic potential to increase the preparedness capacity at both regional and national levels. This diagnostic platform will include the validation of Mitra VAMS devices for gathering blood samples for the diagnostic procedure. The platform will be tested and validated using adult subject-matched serum samples col |
| Who can participate | 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. |
| Ages | 2 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Istituto Zooprofilattico Sperimentale delle Venezie |
| Locations | Padova, Italy, Italy; Padova, Italy, Italy |
| Start date | 2025-04-15 |
| NCT ID | NCT06939556 |
| Official listing | https://clinicaltrials.gov/study/NCT06939556 |