* For research use only, not for use in diagnostic procedures.
Intended Use
The E. coli Device test is a rapid chromatographic immunoassay for the qualitative detection of E.coli O157 antigens in human faeces specimens to aid in the diagnosis of E. coli infections.
Stool
Strip
The detection of E. coli O157:H7 showed a 100% of concordance in sensitivity.
Product Introduction
General Description
E. coli O157:H7 is one of hundreds of strains of the bacterium Escherichia coli. Although most strains are harmless, this strain produces a powerful toxin that can cause severe illness. E. coli O157:H7 has been found in the intestines of healthy cattle, deer, goats, and sheep. E. coli O157:H7 was first recognized as a cause of illness in 1982 during an outbreak of severe bloody diarrhea; the outbreak was traced to contaminated hamburgers. Since then, more infections in all over the world have been caused by eating undercooked ground beef than by any other food.
Principle Of The Test
The E. coli Device is a qualitative lateral flow immunoassay for the detection of Escherichia coli antigen in human faeces samples. The membrane is pre-coated with monoclonal antibodies against E. coli O157 antigens on the test line region. During testing, the sample reacts with the particle coated with anti-E. coli O157 antibodies which was pre-dried on the test strip. The mixture moves upward on the membrane by capillary action. In the case of a positive result the specific antibodies present on the membrane will react with the mixture conjugate and generate a coloured line. A green coloured band always appears in the control line and serves as verification that sufficient volume was added, that proper flow was obtained and as an internal control for the reagents.