Performance Study with the SiMoT System for in Vitro Diagnostic Tests

Condition(s) studied

Investigational drug(s) / intervention(s)

analytical performance study: analytical performance study on left-over samples with the SiMoT IVD system for in vitro diagnostic tests

Study summary

Advanced and performing technologies able to analyze specific biomarkers for the diagnosis, prognosis and prediction as well as for the monitoring, the personalized care and the evaluation of the therapeutic response to pathologies, is currently considered extremely relevant. Such technologies work only if molecular markers specific for a given pathology have been already validated. This approach is considered of strategic importance for the health and well-being of citizens as well as for the sustainability of public spending. Often, however, the analysis of the markers is carried out on tissues or fluids of the organs involved, being hence quite invasive procedures. In this scenario, it is strategic to develop devices and platforms that allow the analysis of markers in a minimally invasive or non-invasive way, through the analysis of peripheral biological fluids, such as blood or urine. The goal is to provide clinicians with the attacker's advantage against a plethora of progressive diseases by mass-screening individuals who are affected by a disease long before symptoms appear or to allow the identification of those patients who have a high probability of recurring or responding to target-oriented pharmacological approaches. This study pertains to the definition of the analytical performance of the Single-Sensor Single-Molecule with a large Transistor (SiMoT) device. In the context of the present performance study, the IVD SiMoT system will be equipped with an accessory-cartridge developed and produced without any diagnostic purpose but only to verify the analytical performance of the SiMoT system, in the detection of exogenous biochemical molecules suitably selected to act as markers of interest.

Eligibility

Primary outcome measure(s)

• To evaluate the analytical performance in plasma, serum, and urine samples supplemented with non-endogenous molecules (three proteins and two nucleotide sequences) of the SiMoT handheld device — December 2024
  Qualitative detection of specific marker at single molecule level

Trial sites (1)