Vibrio cholerae O1 (VC O1) Rapid Test Cassette (Feces)

【SUMMARY】
Cholera is an acute watery diarrheal disease caused mainly by Vibrio cholerae serogroup O1 and less commonly by V. cholerae O139. Cholera 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. Cholera 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 (VC O1) Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Vibrio cholerae O1 in human feces, providing results in 10 minutes. The test utilizes antibodies specific for VC O1 antigens to selectively detect VC O1 antigens in human feces or environment water specimens.

【DIRECTIONS FOR USE】
Allow the test cassette, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
For Fecal Specimens
1. To collect fecal specimens:
Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen collection container to obtain maximum antigens (if present). Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8°C if not tested within 6 hours. For long term storage, specimens should be kept below -20°C.
2. To process fecal specimens:
• For Solid Specimens:
Unscrew the cap of the specimen collection tube，then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.
• For Liquid Specimens:
Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops of the liquid feces (approximately 80 μL) into the specimen collection tube containing the extraction buffer.
• Tighten the cap onto the specimen collection tube, and then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the tube alone for 2 minutes.
3. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch
4. Hold the specimen collection tube upright and open the cap onto the specimen collection specimen (approximately 80μL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
5. Read results at 10 minutes after dispensing the specimen. Do not read results after 20 minutes. Note: If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80 μL of supernatant, dispense into the specimen well (S) of a new test cassette and start afresh following the instructions mentioned above.