Official Title
Development and Validation of (Bio)Sensors for the Identification of Pathogens
Brief Summary

The recent COVID-19 pandemic has revealed the need to develop tests that are accurate,rapid, and inexpensive for the diagnosis of infectious diseases. This problem is relevantnot only for viruses, but also for bacteria and parasites: the identification ofpathogens at low concentrations by simple and accurate methods is still largelyunsatisfied because these microorganisms are structurally complex and are incorporated incomposite and diverse biological samples, which can create relevant interferences inpathogens' detection. Direct diagnostic approaches, such as microscopic examination,culture and molecular testing are carried out in equipped laboratories and require longwaiting times to obtain the results. Recently developed point-of-care (POC) tests are agroup of technologies that miniaturize tests into portable devices such that they can beperformed both in well-equipped laboratories and outside the conventional laboratorysetting. The present study aims to explore the feasibility and adaptability of newlydeveloped platforms to detect: 1. a virus (SARS-CoV2), 2. a bacterium (Pseudomonasaeruginosa) and 3. a protozoan parasite (Leishmania infantum) in clinical specimens, suchas blood and respiratory samples. These newly developed platforms are expected toovercome the current limitations of molecular testing (high cost, time required and needfor well-equipped laboratories) and rapid testing (high number of false-negativeresults). In addition, the newly developed platforms may have important clinicalapplication in low-income countries, which will benefit from a simple and inexpensiveapproach to detect the many infectious diseases that affect millions of people each year.

Detailed Description

Not Provided

Recruiting
Infections
Infection, Bacterial
Infection Viral
Infection, Parasite
SARS CoV 2 Infection
Pseudomonas Aeruginosa Infection
Leishmania Infantum Disease

Other: Nanobiotechnology platforms

The analyses will be carried out using the novel devices, which are of two types:

1. The first type of nanobiotechnological platform encompasses the hybridization of
pathogen nucleic acids - that may be present in the clinical specimen - by employing
specific molecular probes.

2. The second type of nanobiotechnological platform encompasses the use of capture
bacteriophages or "bait Phages" to specifically detect bacterial or protozoan cell
surface antigens (in the case of P. aeruginosa or L. infantum respectively) or viral
particles (in the case of SARS-CoV2) and the use of reporter bacteriophages
("transducer Phages") for the transduction of the electrochemiluminescent signal.

Eligibility Criteria

Inclusion Criteria:

- Obtaining informed consent

- Age ≥ 18 years

- Patients who meet one of the following conditions: SARS-CoV2 positive patients
(group 1), SARS-CoV2 negative patients (group 2), P. aeruginosa positive patients
(group 3), P. aeruginosa negative patients (group 4), L. infantum positive patients
(group 5), L. infantum negative patients (group 6).

Exclusion Criteria:

- None

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

Department of Medical and Surgical Sciences, University of Bologna
Bologna, Italy

Investigator: Stefania Varani, MD, PhD
stefania.varani@unibo.it

Investigator: Tiziana Lazzarotto, PhD

Contacts

Stefania Varani, MD, PhD
+39 0512143013
stefania.varani@unibo.it

Luca Prodi, PhD
luca.prodi@unibo.it

Tiziana Lazzarotto, PhD, Principal Investigator
University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna

University of Bologna
NCT Number
Keywords
Infections
Platform
nanobiotechnological platforms
bacterial
Viral
protozoan
Diagnostic
point of care test
MeSH Terms
Infections
Communicable Diseases
COVID-19
Pseudomonas Infections
Bacterial Infections
Virus Diseases
Parasitic Diseases