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Immunoassays for Diarrhea2022-10-18T15:56:05+00:00

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Comprehensive Gastro-Intestinal Solutions

Comprehensive Gastro-Intestinal Solutions

Comprehensive Gastro-Intestinal Solutions

Immunoassays for Diarrhea

Calprotectin

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.

Fecal Occult Blood

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.

Lactoferrin

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

Pancreatic Elastase

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.

Anti-gliadin Assay

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.

Anti-tissue Transglutaminase tTG Assay

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).

Zonulin Assay

The Genesis Zonulin Stool ELISA* is intended for the quantitative determination of zonulin family peptides (ZFP) in human stool samples. Zonulin is a human protein analog to the zonula occludens toxin derived from Vibrio cholerae, which regulates tight junctions of the digestive tract. Zonulin binds to a specific receptor on the surface of intestinal epithelia and triggers a cascade of biochemical events which induce tight junction disassembly and a subsequent permeability increase of the intestinal epithelia, allowing some substances to pass through and activate immune reactions. Several metabolic traits linked to increased gut permeability include insulin resistance and obesity.

Bile Acids Assay

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

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References

Everhart, J. E. 1994. Digestive Diseases in the United States: Epidemiology and Impact. U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. U.S. Government Printing Office, NIH Publication no. 94-1447. 

Fine., K.D., F. Ogunji, J. George, M. Niehaus, and R.L. Guerrant. 1998. Utility of a rapid fecal latex agglutination test detecting the neutrophil protein lactoferrin for diagnosing inflammatory causes of chronic diarrhea. Am. J. Gastroenterol. 93:1300-1305. 

Guerrant, R.L., V. Araujo, E. Soares, K. Kotloff, A. Lima, W. Cooper, and A. Lee. 1992. Measurement of fecal lactoferrin as a marker of fecal leukocytes. J. Clin. Microbiol. 30:1238-1242. 

Harris, J. C., H. L. DuPont, and B. R. Hornick. 1971. Fecal leukocytes in diarrheal illness. Ann. Intern. Med. 76:697-703. 

Huicho L., V. Garaycochea, N. Uchima, R. Zerpa, and R.L. Guerrant. 1997. Fecal lactoferrin, fecal leukocytes, and occult blood in the diagnostic approach to childhood invasive diarrhea. Pediatr. Infect. Dis. J. 16(7):644-647. 

Kane, S., W. Sandborn, P. Rufo, A. Zholudev, J. Boone, D. Lyerly, M. Camilleri, and S. Hanauer. 2003. Fecal lactoferrin is a sensitive and specific marker in identifying intestinal inflammation. Am. J. Gastroenterol. 98:1309-1314. 

Kayazawa, M., O. Saitoh, K. Kojima, K. Nakagawa, S. Tanaka, K. Tabata, R. Maysuse, K. Uchida, M. Hoshimoto, I. Hirata, and K. Katsu. 2002. Lactoferrin in whole gut lavage fluid as a marker for disease activity in inflammatory bowel disease: Comparison with other neutrophil-derived proteins. Am. J. Gastroenterol. 97:360-369. 

Parsi, M., B. Shen, J. Achkar, F. Remzi, J. Goldblum, J. Boone, D. Lin, J. Connor, V. Fazio, and B. Lashner. 2004. Fecal lactoferrin for the diagnosis of symptomatic patients with ileal pouch-anal anastomosis. Gastroenterology 126:1280-1286. 

Sartor, R. B. 1995. Microbial agents in pathogenesis, differential diagnosis, and complications of inflammatory bowel disease. In M. Blaser, P. Smith, J. Ravdin, H. Greenberg, and R. Guerrant (ed.), Infections of the Gastrointestinal Tract. Raven Press, New York, NY. 

Sugi, K., O. I. Saitoh, and K. Katsu. 1996. Fecal lactoferrin as a marker for disease activity in inflammatory bowel disease: Comparison with other neutrophil-derived proteins. Am. J. Gastroenterol. 91:927-934.

Camilleri, M., & Vijayvargiya, P. (2020). The role of bile acids in chronic diarrhea. The American journal of gastroenterology, 11510, 1596.

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