It is an object of the present invention to provide an alternative method for diagnosing celiac disease (CD), which is based on Raman spectrophotometric analysis, operating directly on human serum in a non-invasive and non- destructive manner. The present invention achieves the aforesaid objects by providing a method as set out in the appended claims. Deconvolution may be used to recognize peaks within a band, when the latter is noisy, as well as to clean up the tails of the band affected by noise and overlapping. Therefore, performing such a mathematical operation allows to clean the spectrum from the observed noise and to identify the possible presence of other peaks, not visible on the original spectrum. As a result of such a cleaning, the sum of the areas of the individual Gaussians related to the second band and the sum of the areas of the individual Gaussians related to the third band, obtained with the deconvolution performed in the regions of interest, are different and more representative, with respect to the area of the band considered and referable to the original spectrum. With the aim of identifying a procedural path which exclusively takes into account a physical investigation technique, such as the Raman spectroscopy, a methodology has been developed based on the analysis of the serum of patients by means of the Raman spectrometer. The new methodology of the present invention has several advantages: - extremely low cost, with respect to the currently used serological techniques, which are based on the ELISA tech- nique, which requires the use of special diagnostic kits; - simplicity of use, experimental repeatability, and speed of execution; - the technique is not invasive; - the technique is not destructive; in fact, the sample in question can be stored and analyzed several times over time, since the only limit of the analysis is given by the degradation of the sample itself. It is one of the objectives to add a highly performing diagnostic test to the battery of serological tests with the aim of totally avoiding invasive tests. The methodology suggested for the diagnosis of Celiac Disease (CD) is based solely on the analysis of human serum by means of the use of Raman spectroscopy and the consequent analysis of the spectrum by calculating the ratio between well-defined areas of the region. Starting from a serum sample, which contains information on the whole human body, and not information attributable to an individual pathology, it was possible to identify three regions, whose areas A1, A2 and A3, taken individually, are not capable of discriminating the patient affected by CD with respect to the healthy one, but, by means of the A3/A1 and A2/A1 ratios, it is possible to diagnose CD in patients, with at least a 97% reliability proven by statistical analysis. Further features and advantages of the invention will become apparent in light of the detailed description of some exemplary but not exclusive embodiments. The dependent claims describe particular embodiments of the invention.

CELIAC DISEASE DIAGNOSIS METHOD

Giuseppe Acri
;
Bramanti Placido;Testagrossa Barbara;Costa Stefano;
2020-01-01

Abstract

It is an object of the present invention to provide an alternative method for diagnosing celiac disease (CD), which is based on Raman spectrophotometric analysis, operating directly on human serum in a non-invasive and non- destructive manner. The present invention achieves the aforesaid objects by providing a method as set out in the appended claims. Deconvolution may be used to recognize peaks within a band, when the latter is noisy, as well as to clean up the tails of the band affected by noise and overlapping. Therefore, performing such a mathematical operation allows to clean the spectrum from the observed noise and to identify the possible presence of other peaks, not visible on the original spectrum. As a result of such a cleaning, the sum of the areas of the individual Gaussians related to the second band and the sum of the areas of the individual Gaussians related to the third band, obtained with the deconvolution performed in the regions of interest, are different and more representative, with respect to the area of the band considered and referable to the original spectrum. With the aim of identifying a procedural path which exclusively takes into account a physical investigation technique, such as the Raman spectroscopy, a methodology has been developed based on the analysis of the serum of patients by means of the Raman spectrometer. The new methodology of the present invention has several advantages: - extremely low cost, with respect to the currently used serological techniques, which are based on the ELISA tech- nique, which requires the use of special diagnostic kits; - simplicity of use, experimental repeatability, and speed of execution; - the technique is not invasive; - the technique is not destructive; in fact, the sample in question can be stored and analyzed several times over time, since the only limit of the analysis is given by the degradation of the sample itself. It is one of the objectives to add a highly performing diagnostic test to the battery of serological tests with the aim of totally avoiding invasive tests. The methodology suggested for the diagnosis of Celiac Disease (CD) is based solely on the analysis of human serum by means of the use of Raman spectroscopy and the consequent analysis of the spectrum by calculating the ratio between well-defined areas of the region. Starting from a serum sample, which contains information on the whole human body, and not information attributable to an individual pathology, it was possible to identify three regions, whose areas A1, A2 and A3, taken individually, are not capable of discriminating the patient affected by CD with respect to the healthy one, but, by means of the A3/A1 and A2/A1 ratios, it is possible to diagnose CD in patients, with at least a 97% reliability proven by statistical analysis. Further features and advantages of the invention will become apparent in light of the detailed description of some exemplary but not exclusive embodiments. The dependent claims describe particular embodiments of the invention.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11570/3284589
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