H. pylori Stool Rapid Test Strip (Cassette) INQUIRY

Cat.No: RTS-027
Cat#: RTS-027

Product Name: H. pylori Stool Rapid Test Strip (Cassette)

INTEND USE:

The Rapid Helicobacter pylori test strip is a rapid chromatographic immunoassay for the qualitative detection of H. pylori antigens in human feces specimens to aid in the diagnosis of H. pylori infection.

PRINCIPLE OF THE TEST:

 The Rapid Helicobacter pylori stool test strip is a qualitative lateral flow immunoassay for the detection of Helicobacter pylori in feces samples. The membrane is pre-coated with monoclonal antibodies against H. pylori antigens on the test line region. During testing, the sample reacts with particle coated with anti-H. pylori 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 red coloured line 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.
 
REAGENTS AND MATERIALS PROVIDED:
 
Rapid Test Device: 20 devices
Product Introduction: 1 copy
Specimen collection vials with buffer


Detection limit:
 
The detection limit test is 0.78 ng/mL.
 
Sensitivity and specificity: 
 
Sensitivity: >94% and specificity >99%.
 
Cross-Reactivity:
 
It was performed an evaluation to determine the cross reactivity of Rapid Helicobacter pylori test strip. There is not cross reactivity with common intestinal pathogens, other organisms and substances occasionally present in feces: Campylobacter, Salmonella, Staphylococcus aureus, Clostridium difficile, Listeria monocytogenes, Yersinia enterocolitica, Escherichia coli O157:H7, Shigella.
 
STORAGE:
 
Store at 15-25°C, DO NOT FREEZE or use beyond the expiration date .The shelf life is 12 months.


 




 
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