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Clinical Trials in Italy / NCT06702540
Active, not recruiting Observational

Bio-reconfigurable Electronic Platform for Multiplex Detection of Viral Respiratory Pathogens

NCT06702540 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2020-03-19
Last updated
2024-11-25

Condition(s) studied

COVID 19

Investigational drug(s) / intervention(s)

Biosensor chip

Biosensor chip: An electronic platform measuring the impedance variation between microelectrodes is used upon capturing the target biomolecule by a selective bioprobe previously grafted over the biosensor surface. The required sensitivity will be achieved by operating the biosensor in lock-in mode, which ensures the highest resolution in tracking amplitude and phase variations of impedance signals.

Study summary

This project focuses on developing a cutting-edge electronic biosensor platform for highly sensitive and specific detection of target biomolecules, with initial applications targeting SARS-CoV-2 detection. The system operates on impedance measurement between microelectrodes, utilizing lock-in mode for unparalleled resolution (1 ppm). Enhanced signal detection is achieved via functionalized polystyrene microbeads that amplify impedance changes, building on prior success in Dengue virus antibody detection.

Key innovations include Differential Impedance Sensing across multiple channels for real-time comparative analysis of various targets, and a biosensor chip modified with DMA-based functional polymers for optimal probe immobilization and target interaction. The biosensor integrates with a pre-existing microfluidic system and supports whole-virus detection using DNA-labelled antibodies against SARS-CoV-2 spike protein, coupled with complementary oligonucleotide-functionalized beads. This strategy is complemented by antigen-specific detection for practical applications such as point-of-care testing in pharmacies.

The project includes a retrospective study analyzing anonymized respiratory and plasma samples from a COVID-19 biobank to validate the platform's sensitivity in detecting viral particles. These efforts aim to advance diagnostic technologies for respiratory infections with a focus on safety, scalability, and versatility.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Samples tested for respiratory viruses, stored at the San Raffaele institutional COVID-19 clinical-biological biobank (COVID-BioB, NCT04318366). Exclusion Criteria: * None

Primary outcome measure(s)

  • Validation of the biosensor platform with nasopharyngeal swabs — 12 months
    Real-time impedance measurement in randomized respiratory samples to detect respiratory viruses

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffaele Milan Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06702540 on ClinicalTrials.gov ↗ ← All trials in Italy