4006 – ASCA IgA

 

 

 

 

Highlights

•Use of monoclonal antibodies against Saccharomyces cerevisiae (ASCA)
• Ready-to-use (exception: wash buffer), color- and barcoded reagents
• Quality assured handling in routine laboratories
• Short incubation times at room temperature (20–25 °C)
• Supports differentiation of Crohn’s disease and ulcerative colitis (in combination with aANCA)
• Excellent diagnostic sensitivity and specificity shortly after onset of the disease
• Aids in the diagnosis of Crohn’s disease
• High precision and linearity within the measurement range
• CE marked
• Manual professional in vitro diagnostic use


Intended Purpose

The ASCA IgA is a quantitative immunoassay for the determination of IgA antibodies against Saccharomyces cerevisiae in human serum. The ASCA IgA 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 development of these diseases.An important serological marker for the differential diagnosis of Crohn’s disease is the determination of IgA and IgG antibodies to Saccharomyces cerevisiae, which are highly prevalent (70 %) in patients with CD and atypical antineutrophile cytoplasmatic antigens (aANCA). Thus, ASCA, in combination with the detection of autoantibodies to atypical anti-neutrophil cytoplasmic antigens (aANCA), are a valid parameter for the differentiation of Crohn’s disease and ulcerative colitis.

Publications

Product Specifications

Title ASCA IgA
Product code 4006
Indication Crohn’s disease
Description Enzyme immunoassay for the quantitative determination of IgA antibodies against Saccharomyces cerevisiae in human serum
Format Microtiter plate coated with mannan from Saccharomyces cerevisiae
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.