The Binding Site Inc has received FDA clearance for use of its ASCA IgG and ASCA IgA ELISA assays to differentiate between ulcerative colitis (UC) and Crohn’s disease (CD), the two major forms of inflammatory bowel disease (IBD). While they are two distinct diseases, they present in similar ways clinically, even with thorough pathological examination. However, correct diagnosis of UC and CD has major implications on the choice of treatment, surgical procedures, and long-term prognosis.
     Recent literature has highlighted the prognostic value of ASCA autoantibodies in IBD. When used in conjunction with perinuclear antineutrophil cytoplasmic antibodies (P-ANCA), ASCA occurs in 50% to 89% of CD patients, but in less than 10% of UC patients. P-ANCA is positive in 60% to 80% of UC patients. Combined, these two serological markers assist in the diagnosis and differentiation of IBD.
     The Binding Site BINDAZYME™ ASCA ELISA kits are now designated as suitable for in vitro diagnostic use and enable quantitation of IgA and IgG autoantibodies to ASCA. Each kit contains eight-well break-apart ELISA strips for economy of use; five prediluted calibrators; positive and negative controls; and ready-to-use, conjugate, TMB substrate and stop solution. The assays are compatible with most automated ELISA systems and offer 30-minute incubation times for maximum sample throughput.

The Binding Site Inc
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