for the measurement of total endogenous lactoferrin, anti-Saccharomyces cerevisiae antibodies (ASCA) and anti-neutrophil cytoplasmic antibodies (ANCA) in human feces; kits

Inventors

Boone, James Hunter • Lyerly, David Maxwell • Wilkins, Tracy Dale

Assignees

Techlab Inc

Abstract

A method for the differentiation of inflammatory bowel disease (IBD) from irritable bowel disease (IBS) followed by distinguishing ulcerative colitis and Crohn's disease from other gastrointestinal illnesses. This highly differential method first uses the presence of elevated lactoferrin as a marker of intestinal inflammation to differentiate IBD from IBS. Patients suspected of IBD are then analyzed for fecal anti-Saccharomyces cerevisiae antibodies (ASCA) as an indicator of Crohn's disease and fecal anti-neutrophil cytoplasmic antibodies (ANCA) as an indicator of ulcerative colitis. IBD patients are further monitored for intestinal inflammation using fecal lactoferrin to evaluate the effectiveness of medical therapy and to predict relapse. The apparatus comprises either a qualitative enzyme-linked immunoassay or other immunoassay that utilizes antibodies specific to human immunoglobins for the measurement of total endogenous lactoferrin, ASCA and ANCA in human feces. The method and apparatus can be used by healthcare providers to identify IBD and distinguish ulcerative colitis from Crohn's disease.

Core Innovation

The invention provides a method for testing fecal samples from persons presenting with symptoms common to inflammatory bowel disease and irritable bowel syndrome. The method obtains a fecal sample, dilutes the sample, and determines that the sample contains an elevated level of lactoferrin compared to a lactoferrin level in a healthy control. The method then measures an elevated level of anti-Saccharomyces cerevisiae antibodies (ASCA) and measures an elevated level of anti-neutrophil cytoplasmic antibodies (ANCA).

Crohn’s disease is diagnosed when the sample contains an elevated level of ASCA compared to an ASCA level in a healthy control and not an elevated level of ANCA compared to an ANCA level in a healthy control. Ulcerative colitis is diagnosed when the sample contains an elevated level of ANCA compared to an ANCA level in a healthy control and not an elevated level of ASCA compared to an ASCA level in a healthy control. The diagnostic linkage is based on elevated fecal lactoferrin followed by differential elevations of ASCA and ANCA.

The disclosed testing includes measuring lactoferrin, ASCA, and ANCA using immunoassay formats, including enzyme-linked immunoassays, lateral flow membrane tests, and immunoassays utilizing antibodies. In specific formats, the method uses immobilized polyclonal antibodies to endogenous lactoferrin and determines optical density of a readable sample. Additional formats measure ASCA and ANCA using antigen contact and enzyme-linked antibody binding, followed by determining optical density of the readable sample.

Claims Coverage

Independent claim clm-00001 defines a fecal testing and diagnosis sequence using elevated lactoferrin with differential ASCA and ANCA elevations versus healthy controls. The independent claim includes multiple inventive elements: sample obtaining and dilution, lactoferrin elevation determination relative to healthy controls, measurement of ASCA and ANCA elevations, and rule-based diagnosis of Crohn’s disease or ulcerative colitis based on differential antibody elevation patterns.

The independent claim is directed to diagnosing Crohn’s disease and ulcerative colitis from fecal samples by requiring elevated lactoferrin relative to healthy controls and then applying differential elevation rules for ASCA versus ANCA to select the diagnosis.

Stated Advantages

Documented Applications

No documented applications found