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The FIDIS™ Celiac kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. Celian IgA is designed for the simultaneous detection of human IgA isotype antibodies directed against Gliadin and Tissue Transglutaminase Enzyme. Celiac IgG is designed for the detection of human IgG isotype antibodies directed against Gliadin. The presence of these antibodies can be used in conjunction with clinical findings to aid in the diagnosis of Celiac disease. The FIDIS™ Celiac kit is to be used on serum only. FIDIS™ Celiac kits are to be used on FIDIS™ Analyser, software and washer. For in vitro diagnostic use.

FIDISTM Celiac is based on Luminex 100TM Technology. The Luminex technology (LabMAP™, Laboratory Multi-Analyte Profiling) is a unique system I ho handler tooning of microspheres, flow cytometer, high speed digital signal processor and an X-Y platform for reading 96-well microtiter plates facilitating automated sample acquisition. This combination allows the diagnostic of multiple biological analytes simultaneously. This multiplexed microsphere-based flow cytometric assay involves fluorescent polystyrene microspheres. The antigen-coated microspheres are mixed and incubated with sample containing the analytes to be detected. A fluorochrome-conjugated detection molecule is subsequently incubated for analyte quantification. The flow cytometer is equipped with a powerful digital signal processor and two lasers. A red "classification" laser, excites fluorescent molecules intrinsic embedded to the microspheres and a green "reporter" laser, excites the extrinsic fluochrome (Phycoerythrin or Alexa-532nm) bound to the microsphere surface. During the sample reading, the flow cytometer analyzes individual microsphere, first, by size, and, second, by fluorescence emissions. Digital signal processors and computers algorithms provide simultaneous real-time acquisition of classification and reporter fluorescence signals output from the microspheres. Upon excitation, the emitted fluorescent signal from the microspheres travels through the optics paths to the individual detectors. According to the fluorescence ratio detected by the red laser, each microsphere is classified into on the basis of its unique fluorescence intensity which allows identifying which analyte is being tested. At the same time, the green "reporter" laser beam excites the external second molecule fluorescence to quantify the specific reaction related to each analyte. Each antigen required for the assay is covalently coupled to an individual set of microspheres through its surface functional groups. The different antigen coupled microspheres are mixed together to constitute the final microspheres reagent. Celiac IgA allows the detection of antigliadin and anti-tissue transglutaminase IgA isotype antibodies. Celiac IgG allows the detection of anti-gliadin IgG isotype antibodies. The test is performed in a 96 wells blank microplate including a filtering membrane at the bottom of the wells. In the first step, the sample is distributed in duplicate for the 2 isotypes (IgA and IgG) selected in each well containing respectively the Celiac A microspheres mixture, for the IgA isotype and the Celiac G microspheres mixture for the IgG isotype. After incubation, a wash step through a filtration process will eliminate the unbound antibodies. A specific conjugate consisting of either anti-human IgA or IgG antibodies coupled to phycoerythrin, is added to the mixture. It will bind to the previously captured antibodies. The reaction is then directly measured by the flow cytometer, which categorizes each microspheres set according to its fluorescence colour the microspheres while simultaneously measuring the average fluorescence emitted by the conjugate. A calibration system allows expressing by interpolation the titer of the sample for each antibody specificity using a specific software developed by bmd. The mixed and antigen-coated microspheres are first incubated with the sample to be analyzed. After the washing step, a phycoerythrin (PE)-labelled secondary anti-human IgA conjugate is added for antibodies quantifications at the surface of each microsphere set. The microspheres are classified on the basis of their unique fluorescence intensity ratio that allows the identity of analyte being tested. Each dot in a white plot corresponds to an individual microsphere.