Abstract: Clostridium difficile disease involves a range of clinical presentations ranging from mild to self-limiting diarrhea to life-threatening pseudomembranous colitis and megacolon. Cases of C. difficile are 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 of C. difficile disease is detected using a biomarker panel that includes C. difficile antigen (GDH), toxins A and B, and fecal lactoferrin. In patients suspected of C. difficile disease, if GDH is detected indicating the presence of C. difficile, and then toxins A and/or B are detected to indicate toxigenic C. difficile and support a diagnosis of C. difficile-associated disease, fecal lactoferrin concentrations are measured to determine severity of the disease by indicating the amount of intestinal inflammation.

Abstract: Clostridium difficile 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 of C. difficile are 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 toxigenic C. difficile and cannot rule out carrier status. Utilization of a biomarker panel that includes C. difficile antigen (GDH), toxins A and B, and fecal lactoferrin allows clinicians to differentiate between a carrier state and active state of C. difficile and allows for monitoring to evaluate the effectiveness of treatment.

Abstract: 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.

Abstract: 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.

Abstract: Accurate and fast detection of the presence of Campylobacter disease is important for the proper treatment of patients with Campylobacter infection. Present tests depend upon culture of viable bacteria and identification by microscopy, which requires care, skill, and two or more days for conclusive results. The current invention improves the ease of use and overcomes the limitations of loss of viability and delay inherent in Campylobacter bacterial culture and provides a more rapid alternative for the identification and diagnosis of Campylobacter and campylobacteriosis. The invention provides a new method of detecting Campylobacter by utilizing an outer membrane protein (OMP 18) to develop antibodies for use in immunoassays of bacterial cultures or human fecal samples.

Abstract: 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.

Abstract: Accurate and rapid differentiation of the outbreak strain ribotype 027 from other possible Clostridium difficile (C. difficile) strains, using stool samples, facilitates decision making for treatment options. Cell wall protein V (CwpV) contains a cell wall binding domain conserved among C. difficile strains and a variable domain which is antigenically different among C. difficile strains. In embodiments, antibodies against the 027-specific region in CwpV are used in diagnostic tests to detect ribotype 027 in culture or fecal samples.

Abstract: Clostridium difficile disease involves a range of clinical presentations ranging from mild to self-limiting diarrhea to life-threatening pseudomembranous colitis and megacolon. Cases of C. difficile are 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 of C. difficile disease is detected using a biomarker panel that includes C. difficile antigen (GDH), toxins A and B, and fecal lactoferrin. In patients suspected of C. difficile disease, if GDH is detected indicating the presence of C. difficile, and then toxins A and/or B are detected to indicate toxigenic C. difficile and support a diagnosis of C. difficile-associated disease, fecal lactoferrin concentrations are measured to determine severity of the disease by indicating the amount of intestinal inflammation.

Abstract: Accurate and fast detection of the presence of Clostridium difficile (C. difficile) disease is crucial for the proper treatment of patients with C. difficile infection. Present tests detecting the presence of C. difficile disease are fast and cost effective, but are not very sensitive. Using an ELISA including Cell Wall Protein 84 (Cwp84) increases the sensitivity of the ELISA. Cwp84 may be used alone or in combination with other markers to support a diagnosis of C. difficile-associated disease.

Abstract: Accurate and rapid differentiation of the outbreak strain ribotype 027 from other possible Clostridium difficile (C. difficile) strains, using stool samples, facilitates decision making for treatment options. Cell wall protein V (CwpV) contains a cell wall binding domain conserved among C. difficile strains and a variable domain which is antigenically different among C. difficile strains. In embodiments, antibodies against the 027-specific region in CwpV are used in diagnostic tests to detect ribotype 027 in culture or fecal samples.

Abstract: 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.

Abstract: Accurate and fast detection of the presence of Clostridium difficile (C. difficile) disease is crucial for the proper treatment of patients with C. difficile infection. Present tests detecting the presence of C. difficile disease are fast and cost effective, but are not very sensitive. Using an ELISA including Cell Wall Protein 84 (Cwp84) increases the sensitivity of the ELISA. Cwp84 may be used alone or in combination with other markers to support a diagnosis of C. difficile-associated disease.

Abstract: Clostridium difficile 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 of C. difficile are 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 toxigenic C. difficile and cannot rule out carrier status. Utilization of a biomarker panel that includes C. difficile antigen (GDH), toxins A and B, and fecal lactoferrin allows clinicians to differentiate between a carrier state and active state of C. difficile and allows for monitoring to evaluate the effectiveness of treatment.

Abstract: 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.

Abstract: Clostridium difficile disease involves a range of clinical presentations ranging from mild to self-limiting diarrhea to life-threatening pseudomembranous colitis and megacolon. Cases of C. difficile are 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 of C. difficile disease is detected using a biomarker panel that includes C. difficile antigen (GDH), toxins A and B, and fecal lactoferrin. In patients suspected of C. difficile disease, if GDH is detected indicating the presence of C. difficile, and then toxins A and/or B are detected to indicate toxigenic C. difficile and support a diagnosis of C. difficile-associated disease, fecal lactoferrin concentrations are measured to determine severity of the disease by indicating the amount of intestinal inflammation.

Abstract: Clostridium difficile disease involves a range of clinical presentations ranging from mild to self-limiting diarrhea to life-threatening pseudomembranous colitis and megacolon. Cases of C. difficile are 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 of C. difficile disease is detected using a biomarker panel that includes C. difficile antigen (GDH), toxins A and B, and fecal lactoferrin. In patients suspected of C. difficile disease, if GDH is detected indicating the presence of C. difficile, and then toxins A and/or B are detected to indicate toxigenic C. difficile and support a diagnosis of C. difficile-associated disease, fecal lactoferrin concentrations are measured to determine severity of the disease by indicating the amount of intestinal inflammation.

Abstract: 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.

Abstract: 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.

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.

Abstract: 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.