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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - KardiaTool (An integrated POC solution for non-invasive diagnosis and therapy monitoring of Heart Failure patients)

Teaser

The aim is to translate a laboratory proven concept of a saliva biosensor to the clinical practice for addressing the priority needs in personalized HF diagnostics and therapy monitoring at the point of care.

Summary

Work performed

The work performed is described in Part B.

Final results

Heart failure (HF) is a rapidly diffusing chronic cardiovascular disease and, according to the World Health Organization, it currently represents the main cause of mortality and major morbidity worldwide, particularly for elderly. Patients with HF often present with signs and symptoms that are often nonspecific and with a wide differential diagnosis, making diagnosis by clinical presentation alone challenging. This heterogeneity of presentation often results in delays in definitive diagnosis and treatment, and such delays are linked with poor prognosis. In addition, HF imposes both direct costs to healthcare systems and indirect costs to society through morbidity, unpaid care costs, premature mortality and lost productivity, the estimation of global economic burden of HF is not accurately feasible. Biomarkers, measurable biological markers of a pathological process, have established a growing role in modern medical practice over the last fifty years. They are described as characteristics that provide information about variety biological conditions whether normal or pathological. Biomarkers can thus represent a tool to predict the onset of future HF, to identify its presence when fully developed, to risk stratify affected patients, and possibly to serve as a biological tool to guide therapy for HF has been recently examined. Indeed, the introduction of objective, non-invasive, biologically meaningful biomarkers to clinical assessment has considerably changed the way HF is diagnosed and monitored.
At the same time, saliva represents a promising biological fluid alternative to blood or tissues. Saliva can be easily and unobtrusively collected, even from critical subjects and it is suitable for the screening of a large population, bypassing several drawbacks such as invasiveness, psychologic stress (especially if repeated sampling is needed) and possible health risks for patients and healthcare professionals.
Therefore, to monitor HF biomarkers such as N-terminal pro Brain Natriuretic Peptide (NT-proBNP), tumor necrosis factor-Î± (TNF-Î±), interleukin-10 (IL-10), and cortisol using the novel technology proposed in the KardiaTool Project (e.g. LoC and PoC devices) represents a non-invasive approach, able to anticipate critical HF episodes and to help HF management.
NT-proBNP, TNF-Î±, IL-10 and cortisol are traditionally quantified in plasma or serum by immunochemical techniques. The KardiaTool project has already provided the development of accurate analytical methods for their determination in saliva sample and to validate the accuracy of the KardiaPOC measurements. In particular, an enzyme-linked immunosorbent assay (ELISA) was validated for the first time for salivary levels of NT-proBNP determination. Commercially available ELISAs for TNF-Î± and IL-10 were adapted and validated, as well as an ultra-high-performance liquid chromatography coupled to electrospray source and triple quadrupole mass spectrometry (UHPLC-ESI-QQQ) method for developed and validated for salivary cortisol quantification.
The project addresses the design and development of novel LoC, complex and compact miniaturized systems for HF monitoring. Device design, fabrication, packaging and characterization, as well as customized electronic instrumentation development, are approached from the initial conception to the final LoC in order to generate knowledge, micro devices and complete systems with high added value. A critical contribution of this non-invasive approach of detection hinges on the successful simultaneous detection of four HF biomarkers (NT-proBNP, TNF-a, IL-10, and Cortisol) in saliva.
KardiaTool novelty involves several new scientific approaches, together with the realization and employment of a microfluidic system that includes magnetic planar coils, combined to the use of new MNPs biofunctionalised with specific antibodies for the target molecules and biofunctionalised ImmunoFET for HF analytes detection. The recognition mechanism recalls imm