Vibrio cholerae O1/O139 Combo Rapid Test Cassette (Feces) With CE

A rapid test for the qualitative detection of Vibrio cholerae O1 and Vibrio cholerae O139 in the specimens of human feces. For professional in vitro diagnostic use only.

Application:

The Vibrio cholerae O1/O139 Combo Rapid Test Cassette (Feces) 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.

Description:

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 Combo Rapid Test Cassette (Feces) 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.

How to 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 ul 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.

l 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. Bring the pouch to room temperature before opening it. 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 tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80μL) to each 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.

INTERPRETATION OF RESULTS 
(Please refer to the illustration above)
VC O1 POSITIVE:* Two lines appear in VC O1 window. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Vibrio cholerae O1 antigen present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
VC O139 POSITIVE:* Two lines appear in VC O139 window. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Vibrio cholerae O139 antigen present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
NEGATIVE : One colored line appears in the control line region (C) . No line appears in the test line region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.