The V. cholerae O1/O139 Antigen Combo Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of Vibrio cholerae O1 and/or O139 in human fecal specimens. This kit is intended for use as an aid in the diagnosis of Vibrio cholerae O1 and/or O139 infection. It is for professional in vitro diagnostic use only.

Cholera epidemics, caused by V. cholerae serotype O1, continue to be a devastating disease of immense global significance in many developing countries. Clinically, cholera may range from asymptomatic colonization to severe diarrhea with massive fluid loss, leading to dehydration, electrolyte disturbances, and death. V. cholerae O1 cause this secretory diarrhea by colonization of the small intestine and production of a potent cholera toxin, Because of the clinical and epidemiological importance of cholera, it is critical to determine as quickly as possible whether or not the organism from a patient with watery diarrhea is positive for V. cholerae O1. A fast, simple and reliable method for detecting V. cholerae O1 is a great value for clinicians in managing the disease and for public health officials in instituting control measures.

Cholera is an acute intestinal disease with watery diarrhea, vomiting, high dehydration, acidosis, and circulation disorders. The causative agent of cholera is a gram-negative bacterium, Vibrio cholerae and this is generally transmitted to humans via contaminated water and food. Because of the clinical and epidemiological severity of cholera, it is critical to determine as quickly as possible the presence of V. cholerae O1/O139 in clinical specimens, water and food so that appropriate monitoring and preventive measures can be undertaken by public health authorities.

Conventional culture methods currently available for detection of V. cholerae O1/O139 are time consuming and expensive and lack the necessary sensitivity, particularly for clinical samples from patients previously treated with antibiotics and/or traditional home remedies or for poorly handled samples. Polyclonal antibody-based coagglutination test for V. cholerae O1/O139 requires cross-absorption with staphylococci. The PCR has been reported to be a reliable and sensitive method for the detection of V. cholerae O1/O139. However, PCR requires trained personnel and sophisticated equipment, which are not generally available in all areas of the world, particularly where cholera is a serious and recurrent problem.

Cholera is rare in the United States, cases have been increasing gradually since 2005 in many places including Africa, Southeast Asia and Haiti. (1)