3850 – Anti-GP2 IgG

Highlights

• Use of glycoprotein 2 (GP2) antigens
• Ready-to-use (exception: wash buffer), color- and barcoded reagents
• Quality assured handling in routine laboratories
• Incubation at room temperature
• Quantitative determination of IgG antibodies against GP2
• Calibrated with an internal reference sample
• Results expressed in U/mL
• Excellent diagnostic sensitivity and specificity
• High precision within the measurement range
• CE marked
• Designed for manual in vitro diagnostic use


Intended Use

The Anti-GP2 IgG is a quantitative enzyme-linked immunoassay for the determination of IgG antibodies against glycoprotein 2 (GP2) in human serum. The Anti-GP2 IgG is intended as an aid in the diagnosis of Crohn’s disease in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.


Diagnostic Relevance

Non-specific inflammatory bowel diseases, including Crohn’s disease (CD) (Enteritis regionalis) and ulcerative colitis (UC), involve chronic-remitting inflammatory processes in the intestine. Immunologic, genetic, infectious, and environmental factors contribute to the risk of developing these diseases. Autoantibodies of the exocrine pancreas (PAB) serve as specific serological markers for CD. Membrane-bound pancreatic Glycoprotein 2 (GP2) is the major target of PAB’s. PAB’s against GP2, in combination with the detection of autoantibodies to Saccharomyces cerevisiae (ASCA), which is highly prevalent (70 %) in patients with CD and atypical antineutrophil cytoplasmatic antigens (aANCA), mainly found in patients with UC, could be used as a highly specific serological marker for differential diagnosis of CD to UC.

Publications

Product Specifications

Title Anti-GP2 IgG
Product code 3850
Indication Crohn’s disease
Description Enzyme immunoassay for the quantitative determination of IgG antibodies against glycoprotein 2 in human serum
Format Microtiter plate coated with recombinant human glycoprotein 2
Total incubation time 105 min.
Sample volume 10 µL serum
No. of determinations 96 (89 x 1) + 5 x Calibrators + 2 x Controls

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.