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The Ig plex Celiac DGP Panel is an in vitro diagnostic test for the semi-quantitative detection of the IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (TG) in human serum. The test is intended for use in clinical laboratories as an aid in the disease in conjunction with other laboratory and clinical findings, and requires the sqid-X system.

The Ig plex Celiac DGP Panel is a consumable reagent kit. It is designed to run on the sqid-X system. The kit includes a microarray plate, reporter mix, standards, controls, sample diluents, wash buffer concentrates and a CD-ROM. The assay detects the presences of the IgA and IgG classes of antibody, and the IgA and lgG classes of anti-tissue transglutaminase antibody. This is performed in an integrated fashion on the sqid-X system that reports all analytes simultaneously to aid in the diagnosis of celiac disease. The system is a multiplex immunoassay analyzer that semi-automates the protocol of a specific lg plex assay from plate washing to reporting of all assay markers for each individual patient sample. The system combines manual liquid handling (samples and reagents) with automated steps for washing, scanning, data analyses and reporting. Results for each patient sample are obtained simultaneously for each of the four markers using the results from one well containing one aliquot of the patient's serum. Results are reported independently.

The IgX PLEX™ Celiac Qualitative Assay is an in vitro diagnostic test for the qualitative detection of the IgA and IgG immunoglobulin classes of anti-tissue transglutaminase antibody in serum. The test is intended for use in clinical laboratories as an aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.

The IgX PLEX™ Celiac Qualitative Assay is a consumable reagent kit. It is designed to run on the SQiDworks™ Diagnostics Platform. The kit includes a Microarray Plate, Reporter mix, standards, controls, sample diluents, wash buffer concentrates and a CD-ROM. The Assay Kit detects the presences of the IgG classes of anti-tissue transglutaminase antibody. This is performed in an integrated fashion on the SQiDworks™ Diagnostics Platform (platform) that reports both analytes simultaneously to aid in the diagnosis of Celiac Disease. The platform automates the entire immunoassay procedure from end-to-end, including calibrator/standards and sample pipetting, sample dilution, incubation, washing, and drying. Once the assay's biochemical reactions have completed, the instrument automatically performs a multi-color fluorescent scan of each well in the microarray, analyzes the data, and generates a report containing qualitative results for both assay markers. Results for each patient sample from the IgX PLEX™ Celiac Qualitative assay are obtained simultaneously for each of the two markers using the results from one well containing one aliquot of the patient's serum. Results are reported independently.

The IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform is an in vitro diagnostic test system for the qualitative detection of the IgA and IgM classes of Rheumatoid Factors, and the IgG class of anti-cyclic citrullinated peptide antibodies (CCPproprietary third generation equivalent formulation) in human serum specimens. The IgX PLEXTM Rheumatoid Arthritis Qualitative Assay is intended for use in clinical laboratories as an aid in the diagnosis of Rheumatoid Arthritis in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.

The device consists of the IgX PLEX™ Rheumatoid Arthritis Qualitative Assay (RL1 kit) and the SQiDworks™ Diagnostics Platform (the Platform); the Platform incorporates the SQiDworks™ Integrated Software (the Software). The Platform is a multiplex immunoassay instrument that fully automates the process of a specific IgX PLEX™ Assay from serum transfer to reporting of all assay markers for each individual patient sample. Once the assay's biochemical reactions have completed, the instrument automatically performs a multi-color fluorescent scan of each well in the microarray, analyzes the data, and generates a report containing qualitative results for all assay markers. The SQiDworks Diagnostics Platform also includes numerous internal quality checks and user safety features with fail-safe and interlock mechanisms. The instrument integrates an automated pipetting station, a fluorescent scanner, washing and drying stations, and other ancillary hardware components using dedicated instrument control. In addition, the software provides scheduling, self-verification, data acquisition, data management, analysis algorithms and reporting software. Results for each patient sample from the IgX PLEXIM Rheumatoid Arthritis Qualitative Assay and the SQiDworks™ Diagnostics Platform are obtained simultaneously for cach of the three assay markers: RF IgM, RF IgA and CCP IgG using the results from one well containing one aliquot of the patient's serum. Results are reported independently. The IgX PLEXIM Rheumatoid Arthritis Qualitative Assay (RL1) kit consists of two boxes (with different temperature requirements) of components as described below.