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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-19

Study Completion Date

2025-09-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept

NCT04780334

SARS-CoV Infection Covid19

COMPLETED

Development and Verification of a New Coronavirus Multiplex Nucleic Acid Detection System

NCT04311398

COVID-19

UNKNOWN

Phase I/II Safety, Dose Finding & Antiviral Activity of RD-X19 in Mild/Moderate Outpatient COVID-19

NCT04662671

COVID19

COMPLETED NA

Performance Study with the SiMoT System for in Vitro Diagnostic Tests

NCT06518967

Non-interventional Analytical Performance Study on Left-over Samples

ACTIVE_NOT_RECRUITING

Exploration of Feasability of Blood and Saliva Proteomic Analysis Through Harvesting by Silica Matrix (NanoDx-CoV-19)

NCT04597216

Covid19

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The project stands on the development of an electronic platform performing the measurement of the impedance variation between microelectrodes upon the capture of 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 (1 ppm has been demonstrated by POLIMI on other applications). To enhance the electronic signal, polystyrene microbeads, properly functionalized with oligonucleotides or antibodies, are used to link the target and increase the impedance variation as demonstrated by proponents in the successful detection of antibodies against Dengue virus. To address multiple sensing sites in parallel on the same biosensor chip, allowing real-time comparative analysis on different targets from the same biological sample for augmented detection sensitivity and control, a custom-made electronic platform will be developed to perform Differential Impedance Sensing (i.e., direct comparison between the target sensor and a reference) on multiple channels. The biosensor chip, made of borosilicate with gold microelectrodes, features a specific modification of its surface with functional polymers (a family of N,N-dimethylacrylamide -DMA-based polymers) developed by CNR that form a nanometric hydrophilic film on the chip surface. The functional groups of these copolymers allow the covalent immobilization of the probe preserving its active structure, proper spatial distance, orientation and density, favoring the interaction with the target. The biosensor chip will be integrated into the microfluidic system already available in the group.

SARS-CoV-2 will be targeted with challenging strategies. First, we plan to capture the entire virus in solution using DNA-labelled antibodies directed against the SARS-CoV-2 spike protein.

The sensor area, spotted with oligonucleotide probes complementary to the DNA sequence linked to the antibody, will interact with the DNA-labelled antibodies which have decorated the entire surface of the virus. To increase the impedance variation of the platform polystyrene beads will be used: in particular, they will be modified with the oligonucleotide complementary to that linked to the antibody which have captured the virus. This entire-virus detection methodology, combining the DNA-directed capture of the antigens together with a high sensitivity platform for Differential Impedance Sensing, is absolutely new and expected to be successful based upon the results already achieved by the proponents in the detection of the antibodies in the human blood of persons infected by Dengue virus. In parallel, we intend to extend the use of the electronic platform also to the detection of viral antigens, i.e. Spike protein S or nucleocapside protein N. The use of antigens for the diagnosis of the infection instead of the entire virus, may lead to important practical dropouts as it does not necessitate any particular safety requirement, thus allowing the test to be performed in any location, in particular pharmacies or medical clinics similarly to standard antigenic lateral flow tests.

This is a retrospective monocenter study to test respiratory samples to evaluate the analytical sensitivity of the platform being developed in the project PRIN Prot. 2022EJL28B. The samples are completed anonymized and the samples analyses are performed in order to check the ability of the device to reveal the presence of viral particles in biological matrix such as respiratory samples or, when necessary for set up of instruments, plasma randomized and anonymized samples. No patients or use of clinical data will be involved for the study, but only used the samples stored in the San Raffaele institutional COVID-19 clinical-biological biobank (COVID-BioB, NCT04318366). The samples used for the study were collected during the period 19/03/2020 - 31/05/2024.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID 19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Positive for respiratory viruses

79 retrospective samples tested positive for respiratory viruses

Biosensor chip

Intervention Type DEVICE

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.

Negative to respiratory viruses

79 retrospective samples tested negative to respiratory viruses

Biosensor chip

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE