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

NCT06702540 | Active Not Recruiting

• 2 other identifiers: BIOPLEX 2022EJL28B2022EJL28B
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID 19

Keywords

COVID-19; SARS-CoV-2; Biosensor chip

Outcome Measures

Primary Outcomes (1)

• Validation of the biosensor platform with nasopharyngeal swabs

  Real-time impedance measurement in randomized respiratory samples to detect respiratory viruses

  12 months

Study Arms (2)

Positive for respiratory viruses

79 retrospective samples tested positive for respiratory viruses

Device: Biosensor chip

Negative to respiratory viruses

79 retrospective samples tested negative to respiratory viruses

Device: Biosensor chip

Interventions

Biosensor chip 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; Positive for respiratory viruses

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Samples tested for respiratory viruses, stored at the San Raffaele institutional COVID-19 clinical-biological biobank (COVID-BioB, NCT04318366).

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Politecnico di Milano: collaborator
• Consiglio Nazionale delle Ricerche, Italy: collaborator

Study Sites (1)

IRCCS San Raffaele

Milan, Italy, 20132, Italy

Location

Related Publications (6)

• Liu W, Liu L, Kou G, Zheng Y, Ding Y, Ni W, Wang Q, Tan L, Wu W, Tang S, Xiong Z, Zheng S. Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2. J Clin Microbiol. 2020 May 26;58(6):e00461-20. doi: 10.1128/JCM.00461-20. Print 2020 May 26.

  PMID: 32229605 BACKGROUND

• Seo G, Lee G, Kim MJ, Baek SH, Choi M, Ku KB, Lee CS, Jun S, Park D, Kim HG, Kim SJ, Lee JO, Kim BT, Park EC, Kim SI. Rapid Detection of COVID-19 Causative Virus (SARS-CoV-2) in Human Nasopharyngeal Swab Specimens Using Field-Effect Transistor-Based Biosensor. ACS Nano. 2020 Apr 28;14(4):5135-5142. doi: 10.1021/acsnano.0c02823. Epub 2020 Apr 20.

  PMID: 32293168 BACKGROUND

• Sola L, Damin F, Gagni P, Consonni R, Chiari M. Synthesis of Clickable Coating Polymers by Postpolymerization Modification: Applications in Microarray Technology. Langmuir. 2016 Oct 11;32(40):10284-10295. doi: 10.1021/acs.langmuir.6b02816. Epub 2016 Sep 29.

  PMID: 27632284 BACKGROUND

• Piedimonte P, Sola L, Cretich M, Gori A, Chiari M, Marchisio E, Borga P, Bertacco R, Melloni A, Ferrari G, Sampietro M. Differential Impedance Sensing platform for high selectivity antibody detection down to few counts: A case study on Dengue Virus. Biosens Bioelectron. 2022 Apr 15;202:113996. doi: 10.1016/j.bios.2022.113996. Epub 2022 Jan 15.

  PMID: 35091373 BACKGROUND

• F. Morichetti et al., "Non-Invasive On-Chip Light Observation by Contactless Waveguide Conductivity Monitoring," in IEEE Journal of Selected Topics in Quantum Electronics, vol. 20, no. 4, pp. 292-301, July-Aug. 2014, Art no. 8201710, doi: 10.1109/JSTQE.2014.2300046.

  BACKGROUND

• Ciccarella, Pietro et al. "Multichannel 65 zF rms Resolution CMOS Monolithic Capacitive Sensor for Counting Single Micrometer-Sized Airborne Particles on Chip." IEEE Journal of Solid-State Circuits 51 (2016): 2545-2553.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Analyses performed on plasma samples already stored with nasopharyngeal swabs during the first pandemic COVID-19 waves according to the San Raffaele institutional COVID-19 clinical-biological biobank (COVID-BioB, NCT04318366) procedures.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Microbiology and Virology

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 25, 2024
• Study Start: March 19, 2020
• Primary Completion: May 31, 2024
• Study Completion: September 28, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)