Innovative method for SARS-Cov-2 rapid and low-cost search in respiratory samples: validation with multiple diagnostics and process automation.
1) a clinically validated rapid extraction system of nucleic acids in both symptomatic and asympto- matic subjects, in combination with the diagnostic systems currently in use and a new quantitative diagnostic kit developed as part of the project;
2) a new clinically validated quantitative diagnostic kit for the analytical phase of the diagnostic process. The kit includes the use of unique enhancer solutions, specifically formulated to facilitate direct amplification of viral RNA in the presence of various types of PCR inhibitors, generally present in clinical samples. Integration with an existing analytical assay, which can assess the quality and efficiency of all phases of the diagnostic process, from sampling to amplification of viral genes, avoid false negative results and accurate quantitative evaluation of the viral load;
3) a clinically validated integrated diagnostic platform, with hardware and software implementation, to optimize the efficiency, reliability and high throughput of the pre-analytic and analytical process for the research of SARS-Cov-2, capable of processing up to 2000 samples per day, while ensuring optimal levels of diagnostic sensitivity and safety for operators.