The Genesis Calprotectin Chemiluminescence ELISA* is an in vitro diagnostic chemiluminescent fecal assay intended for quantitatively measuring fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation. The Genesis Calprotectin Chemiluminescence ELISA is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.

The Genesis Calprotectin Chemiluminescence ELISA is the most clinically accurate test on the market and provides the following:

• The best combination of clinical specificity (95.1%) and clinical sensitivity (92.1%) when used as an aid in the differentiation of IBD from IBS.
• Currently, the lowest false positive rate of any calprotectin test on the market.

The Genesis iFOB Chemiluminescence ELISA* is a fecal immunochemical test (FIT) for quantitatively determining human hemoglobin A in stool. Unlike chemical tests that react with the heme component of hemoglobin, this test achieves enhanced specificity via antibodies in this assay recognizing hemoglobin’s globin component.

The sensitivity and range of the assay maximize the number of detectable samples at a single sample dilution, decreasing sample re-tests, recollection, and reporting delays. Physicians are armed with rapid and accurate results the first time.

The Genesis Lactoferrin Assay** is a quantitative ELISA for measuring concentrations of fecal lactoferrin, a marker of fecal leukocytes. Elevated levels of this marker are indicative of intestinal inflammation.

The test can be used as an in vitro diagnostic aid to distinguish patients with active inflammatory bowel disease (IBD) from those with noninflammatory irritable bowel syndrome (IBS). In addition, the test can be used to assess when an IBD patient is in confirmed remission and has responded to treatment.

• Quantitative assay to determine the concentration of fecal lactoferrin present to guide treatment decisions
• Prediluted standards
• Accurate measurement of both solid and liquid fecal samples using a novel pipet design
• Noninvasive

The Genesis Pancreatic Elastase (PE) Chemiluminescence ELISA* is a chemiluminescent immunoassay for the quantitative determination of pancreatic elastase in human stool. Pancreatic elastase (PE or PE-1) refers to a family of chymotrypsin-like elastases (CELAs), digestive proteases produced by acinar cells in the pancreas. PE is highly stable in the intestinal tract, and the concentration of pancreatic elastase in stool correlates well with overall pancreatic enzymatic output. The Genesis Pancreatic Elastase (PE) Chemiluminescence ELISA* Assay detects the CELA3A and CELA3A isoforms of PE.

The Genesis Anti-gliadin Assay* allows for the detection of gliadin, a protein in our common cereals and a constituent of gluten. In gluten intolerance, coeliac Disease (CD), an inflammation of the bowel with shortened jejunal villi, is induced. In this condition, antibodies of IgA- and IgG-isotype to the exogenic antigen gliadin (IgA-AGA, IgG-AGA) may be present, IgA-AGA being the most specific CD marker of the two.

The Genesis Anti-tTG-A ELISA* is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. The assay employing human recombinant transglutaminase crosslinked with gliadin-specific peptides displays neo-epitopes of tTG, which ensures a significantly increased sensitivity and specificity of the test. An assay is a tool for the diagnosis of celiac disease (gluten-sensitive enteropathy).

The Genesis Bile Acids Photometric Assay* is intended for the quantitative determination of bile acids in human stool samples. This assay is designed for the quantitative determination of bile acids in stool. Patients with unexplained diarrhea or irritable bowel syndrome-diarrhea (IBS-D) who have increased fecal bile acid excretion typically have higher BMI, increased stool weight and fat, and accelerated colonic transit compared to patients without increased fecal bile acid excretion

*Genesis Labs utilizes American Laboratory Products, Ltd. (Alpco) technologies in annotated assays

** Genesis Labs utilizes TechLab, Inc. technologies in annotated assays