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CoproELISA C. difficile Toxin A B Assay Kit

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$390.00
SKU:
794-01

 Product Description

Package insert view pdf
 

 

CoproELISA C. difficile Toxin A & B Assay Kit:
For Research Use Only
Size:  1x96 wells
Sensitivity:  Cut-Off Control
Incubation Time:  < 2 hours
Sample Type:  Stool
Sample Size: 0.05 to 0.3g

Product Developed and Manufactured by Savyon Diagnostics


Intended Use
The Eagle Bioscience's CoproELISA C. difficile Tox A/B is an Enzyme-Linked Immunosorbent Assay (ELISA) for detection of C. difficile toxin A and toxin B in human fecal specimens collected from patients suspected of having C. difficile disease. The test results together with the patients history is intended to aid in the diagnosis of C. difficile infection (CDI).The Eagle Biosciences CoproELISA C. difficile Tox A/B Assay Kit is for Research Use Only and is not intended for diagnostic or therapeutic purposes. 

Background

The gram-positive anaerobic bacillus Clostridium difficile is the leading causative agent of antibiotic-associated diarrhea and pseudomembranous colitis. This pathogen is capable of causing disease that could be severe or fatal if not diagnosed on time and treated. Exposure to antibiotics is the major risk factor for C. difficile infection. Infection can develop if the normal gastrointestinal flora is disrupted by antibiotic therapy and a person acquires toxin-producing C. difficile, typically via the fecal-oral route. C. difficile’s key virulence factors are toxin A and toxin B. These toxins show high sequence and functional homology. Toxin A has been described as a tissue damaging enterotoxin which attracts neutrophils and monocytes and toxin B as a potent cytotoxin that degrades the colonic epithelial cells. Most virulent strains produce both toxins, however, strains that are toxin A negative and toxin B positive are also capable of causing. Immunoassay detection of toxin A and toxin B in stool specimen is commonly used as a diagnostic aid.

Assay Principle

CoproELISA C. difficile Toxin A/B is an enzyme immunoassay for the detection of toxin A and toxin B in human feces.  Break-apart microwells are coated with C. difficile toxin-specific polyclonal antibodies. A set of horseradish peroxidase (HRP) conjugated polyclonal anti-toxin A and anti-toxin B antibodies are added to the antibody-coated microwells. Fecal samples are diluted in sample diluent and added to the microwells. In this step C. difficile toxins are specifically marked by the HRP conjugated antibodies and immobilized by the coated antibodies. Unbound conjugate is removed by washing. Upon the addition of TMB-substrate, the substrate is hydrolyzed by the peroxidase, yielding a blue solution of the reduced substrate. Upon the addition of the stop solution, the blue color turns yellow and should be read by an ELISA reader at a wavelength of 450/620 nm. The absorbance is proportional to the level of C. difficile toxins in the sample.

Cross Reaction

The Eagle Biosciences CoproELISA C. difficile toxin A/B test was evaluated using microbial culture isolates and clinical stool specimens. No cross-reactivity was observed with any of the gastrointestinal pathogens and microbes listed: Blastocystis, Campylobacter, Cryptosporidium parvum, Dientamoeba fragilis, Escherichia coli, Entamoeba histolitica, Enterococcus faecali, Enterococcus faesium, Enterococcus avium, Enterococcus aerogenes, Enterococcus cloacae, Enterococcus gallinarum, Enterococcus durans, Giardia lamblia*, Helicobacter pylori*, Klebsiella pneumonia,  Salmonella enterica, and Shigella.

References

  1. Cloud J, Kelly CP, Update on Clostridium difficile associated disease. Curr Opin Gastroenterol. 2007 Jan;23(1):4-9.
  2. Owens RC Jr, Donskey CJ, Gaynes RP, Loo VG, Muto CA., Antimicrobial-associated risk factors for Clostridium difficile infection.Clin Infect Dis. 2008 Jan 15;46 Suppl 1:S19-31.
  3. Kelly CP, Pothoulakis C, LaMont JT., Clostridium difficile colitis. N Engl J Med. 1994 Jan 27;330(4):257-62
  4. Voth DE, Ballard JD., Clostridium difficile toxins: mechanism of action and role in disease. Clin Microbiol Rev. 2005 Apr;18(2):247-63.
  5. Savidge TC, Pan WH, Newman P, O'brien M, Anton PM, Pothoulakis C., Clostridium difficile toxin B is an inflammatory enterotoxin in human intestine. Gastroenterology. 2003 Aug;125(2):413-20.
  6. Pituch H, van den Braak N, van Leeuwen W, van Belkum A, Martirosian G, Obuch-Woszczatyński P, Łuczak M, Meisel-Mikołajczyk F.,Clonal dissemination of a toxin-A-negative/toxin-B-positive Clostridium difficile strain from patients with antibiotic-associated diarrhea in Poland. Clin Microbiol Infect. 2001 Aug;7(8):442-6.
  7. Shin BM, Kuak EY, Yoo SJ, Shin WC, Yoo HM., Emerging toxin A-B+ variant strain of Clostridium difficile responsible for pseudomembranous colitis at a tertiary care hospital in Korea. Diagn Microbiol Infect Dis. 2008 Apr;60(4):333-7.

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20A NW Blvd., Suite 112
Nashua, NH 03063
Email: info@eaglebio.com
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International: +617-419-2019

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