Non-invasive Celiac disease diagnosis
Celiac disease (CD) is an immuno-mediated systemic disorder caused by the ingestion of gluten deriving from foods such as wheat, barley and rye. A combination of CD serology testing and duodenal biopsy sampling is required for the diagnosis of CD. The aim of this patent, based on Raman Spectroscopy on serum, concerns a non invasive methodology for the diagnosis of CD.
The methodology is based on Raman spectroscopy technique and requires a serum sample for the analysis. From obtained spectra, three spectral ranges (1750–1550; 1500–1400; 1015–990) cm-1 were considered and the area ratios, A1450 / A1003 and A1650 / A1003, were calculated to obtain diagnostic information. The overall areas of the three intervals were obtained using the deconvolution function in order to distinguish superimposed and very close bands and to reduce band noise. A subject is assessed as affected if the values of the tested markers A1450 / A1003 and A1650 / A1003 are higher than the threshold values 21.97 and 40.14; otherwise the subject is NON-CD. The reliability of the diagnosis methodology was evaluated with respect to the duodenal biopsy, representative of the Gold Standard, and the ROC curve and the Youden index were also calculated. The obtained values were used to confirm the presence of disease and to exclude the disease in NON-CD subjects.
Further results in the Technical Annex.
- Celiac disease diagnosis without duodenal biopsy.
- Rapid testing;
- Does not require sample pre-treatment;
- Low use of consumables.