Techlab, Inc.

James Hunter Boone

David Maxwell Lyerly

Tracy Dale Wilkins

Richard Littleton Guerrant

Li Chen

Kristen Schwab

Robert J Carman

Jodie Stevens

disease involves a range of clinical presentations ranging from carrier status with other causes of symptoms to mild and self-limiting diarrhea to life-threatening pseudomembranous colitis and megacolon. Cases ofare treated differently depending on the presence and then the severity of disease. Patients that are carriers may not receive treatment with concern of causing the disease. Mild to moderate cases may be treated with metronidazole while severe and relapsing cases are often treated with vancomycin or fidaxomicin. Current molecular assays are highly sensitive for detecting toxigenicand cannot rule out carrier status. Utilization of a biomarker panel that includesantigen (GDH), toxins A and B, and fecal lactoferrin allows clinicians to differentiate between a carrier state and active state ofand allows for monitoring to evaluate the effectiveness of treatment.

Clostridium difficile dehydrogenase and toxin as a biomarker for monitoring infection in patients with clostridium difficile disease and differentiating carrier state from active disease

disease involves a range of clinical presentations ranging from mild to self-limiting diarrhea to life-threatening pseudomembranous colitis and megacolon. Cases ofare treated differently depending on severity of disease. Mild and moderate cases may be treated with metronidazole while moderate-to-severe and relapsing cases are often treated with vancomycin or fidaxomicin. The presence ofdisease is detected using a biomarker panel that includesantigen (GDH), toxins A and B, and fecal lactoferrin. In patients suspected ofdisease, if GDH is detected indicating the presence of, and then toxins A and/or B are detected to indicate toxigenicand support a diagnosis of-associated disease, fecal lactoferrin concentrations are measured to determine severity of the disease by indicating the amount of intestinal inflammation.

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Nucleic acid amplification tests have been widely used in clinical laboratories. Nucleic acid extraction from biological materials is challenging because different unfavorable substances may co-extract and inhibit downstream applications. The present invention relates to a composition of and a method for treating the sample prior, during or post extraction of nucleic acid. More specifically, the claimed invention relates to a composition of and a method for using low concentrations of common organic solvents to remove inhibitors of nucleic acid amplification. The present invention can be used for extracting nucleic acids (DNA/RNA) from bacteria, viruses, parasites, and other biological materials or matrices, including but not limit to, stool samples, body fluids, plants and cultures. The method is rapid, low-cost, and easy to use in a laboratory setting. The nucleic acid extracted in accordance with the invention can be used for nucleic acid amplification reactions.

Nucleic acid extraction using organic solvents to remove inhibitors

The present invention provides assays and devices for detection of substances in liquid samples. The assays and devices utilize passive diffusion between a porous material and a porous membrane containing a specific binding pair member to enable detection of the substance of interest.

Device and method for detection of analytes

A method for aiding in differentiating irritable bowel syndrome from inflammatory bowel disease by determining the level of total endogenous human lactoferrin in clinical specimens, such as feces, mucus and bile, wherein an elevated level of lactoferrin substantially precludes diagnoses of IBS and other noninflammatory etiologies, and a kit usable in such method are provided. Further provided is a method for quantitating the level of total endogenous human lactoferrin in clinical specimens, such as feces, mucus and bile, to monitor gastrointestinal inflammation in persons having inflammatory bowel disease.

Method for diagnosing irritable bowel syndrome and monitoring inflammatory bowel disease

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-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.

Inflammatory bowel disease and irritable bowel syndrome IBD-first chek diagnostic panel

A method and apparatus for the differentiation of ulcerative colitis from Crohn's disease and other gastrointestinal illnesses using the presence of anti-neutrophil cytoplasmic antibodies (ANCA) as a marker of ulcerative colitis is described. The apparatus consists of either a qualitative enzyme-linked immunoassay or other immunoassay that utilizes antibodies specific to human immunoglobulins for the measurement of total endogenous ANCA in a human sample. The method and apparatus can be used by healthcare providers to distinguish ulcerative colitis from Crohn's disease and other gastrointestinal illnesses.

Method for distinguishing ulcerative colitis from Crohn's disease by detecting the presence of fecal anit-neutrophil cytoplasmic antibodies (ANCA)

Method for monitoring gastrointestinal inflammation in persons with inflammatory bowel disease(IBD)

Method for differentiating irritable bowel syndrome from inflammatory bowel disease (IBD) and for monitoring persons with IBD using total endogenous lactoferrin as a marker

A method and apparatus for the differentiation of Crohn's disease from other gastrointestinal illnesses, such as ulcerative colitis and irritable bowel syndrome, using the presence of fecal anti-antibodies (ASCA) as a marker for Crohn's disease are provided. The apparatus includes an enzyme-linked immunoassay or other immunoassay that utilizes antibodies specific to human immunoglobins for the measurement of total endogenous ASCA in a human fecal sample. The method and apparatus may be used by healthcare providers to distinguish Crohn's disease from other gastrointestinal illnesses, such as ulcerative colitis and irritable bowel syndrome.

Method and apparatus for distinguishing Crohn's disease from ulcerative colitis and other gastrointestinal diseases by detecting the presence of fecal antibodies to Saccharomyces cerevisiae

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Christianburg, VA, United States of America

James Hunter Boone