INTENDED USE

The Vibrio cholerae O1/O139 Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Vibrio cholerae O1 and Vibrio cholerae O139 in human feces to aid in the diagnosis of Vibrio cholerae O1 or Vibrio cholerae O139 infection.

SUMMARY

Cholerae is an acute watery diarrheal disease caused mainly by Vibrio choleraee serogroup O1 and less commonly by V. cholerae O139. cholerae can lead to severe diarrhea and death if untreated. V. cholerae O1 and V. cholerae O139 are transmitted through fecal-oral contamination, and cholera is thus predominantly associated with lack of safe drinking water, proper sanitation and personal hygiene. cholerae is an important public health problem in many parts of Asia, Africa and Latin America. Globally, 3–5 million cases and over 100,000 deaths occur annually due to cholera. Countries facing complex emergencies are more vulnerable to cholera outbreaks. The etiological agent of cholera has been identified as Vibrio cholerae (V. cholerae), a gram negative bacterium, which is generally transmitted to humans via contaminated water and food. The species V. cholerae is divided into several serogroups on the basis of O antigens. The subgroups O1 and O139 are of special interest because both can cause epidemic and pandemic cholera. It is critical to determine as quickly as possible the presence of V. cholerae O1 and O139 in clinical specimens, water, and food so that appropriate monitoring and effective preventive measures can be undertaken by public health authorities.
The Vibrio cholerae O1/O139 Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Vibrio cholerae O1 and Vibrio cholerae O139 in human feces, providing results in 10 minutes. The test utilizes antibodies specific for VC O1 and VC O139 antigens to selectively detect VC O1 antigens and VC O139 antigens in human feces.

PRINCIPLE

The Vibrio cholerae O1/O139 Rapid Test is a qualitative, lateral flow immunoassay for the detection of Vibrio cholerae O1 and Vibrio cholerae O139 antigens in human feces.In Vibrio cholerae O1 test, the membrane is pre-coated with anti-Vibrio cholerae O1 antibody on the test line region of the test. During testing, the specimen reacts with the particle coated with anti-Vibrio cholerae O1 antibody. The mixture migrates upward on the membrane by capillary action to react with anti- Vibrio cholerae O1 antibodies on the membrane and generate a colored line.
In Vibrio cholerae O139 test, the membrane is pre-coated with anti-Vibrio cholerae O139 antibody on the test line region of the test. During testing, the specimen reacts with the particle coated with anti-Vibrio cholerae O139 antibody. The mixture migrates upward on the membrane by capillary action to react with anti- Vibrio cholerae O139 antibodies on the membrane and generate a colored line.
The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.