Fecal H. pylori Antigen CLIA Kit


This Chemiluminescence Immunoassay (CLIA) kit is intended for the quantitative determination of Helicobacter pylori (H. pylori) antigen levels in feces using the ECL100 or ECL25 Immunoassay analyzer. The assay is a useful tool in the detection of active H. pylori infection.

​​​​​​​This kit is for in-vitro diagnostics use only.


H. pylori (previously known as Campylobacter pyloridis) is a type of bacteria that infects the stomach and is a common cause of peptic ulcers. H. pylori bacteria can be passed from person to person through direct contact with saliva, vomit or fecal matter. H. pylori can also be spread through contaminated food or water. The infection is normally acquired during childhood. H. pylori usually goes undiagnosed until symptoms of a peptic ulcer occur. H. pylori infection is quite common and is present in about half the people in the world.

​​​​​​​This “sandwich” ELISA is designed, developed and produced for the quantitative and qualitative measurement of H. pylori antigen in stool specimen. The assay utilizes the microplate-based enzyme immunoassay technique by coating highly purified antibody onto the wall of microtiter wells. Assay calibrators and extracted fecal specimen are added to microtiter wells of microplate that was coated with a highly purified monoclonal H. pylori antibody on its wall. During the assay, the H. pylori antigen will be bound to the antibody coated plate after an incubation period. The unbound material is washed away and another HRP-conjugated monoclonal antibody which specifically recognizes the protein of H. pylori is added for further immunoreactions. After an incubation period, the immunocomplex of “H. pylori Antibody – H. pylori Antigen – HRPconjugated Anti-H. pylori Tracer Antibody” is formed if H. pylori antigen is present in the test sample. The unbound tracer antibody and other proteins in buffer matrix are removed in the subsequent washing step. HRP conjugated tracer antibody bound to the well is then incubated with a substrate solution in a timed reaction and then measured in a spectrophotometric microplate reader. The enzymatic activity of the tracer antibody bound to H. pylori proteins captured on the wall of each microtiter well is directly proportional to the amount of H. pylori antigen level in each test specimen.


Catalog no. CL0826
Target Helicobacter pylori Antigen
Species N/A
Method Sandwich CLIA
Tests Per Kit 100 tests
Detection Flash AE Chemiluminescence
Sensitivity / LLOD 0.112 ng/mL
Dynamic Range 0 - 146 ng/mL
Total Incubation Time <30 minutes
Sample Type Stool
Sample Volume 1-2 mL liquid stool sample or 1- 5 grams solid sample.
Storage Temperature 2-8 °C

Selected Literature

  1. Rosenblatt JE, Sloan LM, Schneider SK.  Evaluation of an enzyme-linked immunosorbent assay for the detection of H. Pylori in stool specimens. Diagn Microbiol Infect Dis. 1993 May-Jun; 16(4):337-41.
  2. Stibbs HH, Samadpour M, Manning JF. Enzyme immunoassay for detection of H. Pylori cyst antigens in formalin-fixed and unfixed human stool. J Clin Microbiol. 1988 Sep; 26(9):1665-9.
  3. Ungar BL, Yolken RH, Nash TE, Quinn TC. Enzyme-linked immunosorbent assay for the detection of H. Pylori in fecal specimens. J Infect Dis. 1984 Jan;149(1):90-7
For in-vitro diagnostic use.