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.
【INTENDED USE】
The Vibrio cholerae O1/O139 Combo Rapid Test (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.
【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. 1, 2 Globally, 3–5
million cases and over 100,000 deaths occur annually due to cholera. 3 Countries facing
complex emergencies are more vulnerable to cholera outbreaks. 4 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 (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.
【PRINCIPLE】
The Vibrio cholerae O1/O139 Combo Rapid Test (Feces) 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.
【REAGENTS】
The test cassette contains monoclonal anti-Vibrio cholerae O1 antibody coated particles
and monoclonal anti-Vibrio cholerae O1 antibody coated on the membrane.
The test cassette contains monoclonal anti-Vibrio cholerae O139 antibody coated
particles and monoclonal anti-Vibrio cholerae O139 antibody coated on the membrane.
【PRECAUTIONS】
Please read all the information in this package insert before performing the test.
• For professional use only. For in vitro diagnostic use only.
• Do not use after the expiration date. Do not reuse the test.
• Store in a dry place at 2-30°C (36-86°F), avoiding areas of excess moisture. If the foil
packaging is damaged or has been opened, please do not use.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout all procedures and follow the
standard procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye
protection when specimens are assayed.
• The used test should be discarded according to local regulations.
• Humidity and temperature may adversely affect results.
• Wash hands thoroughly before and after handling.
• Any serious incident that has occurred in relation to the device shall be reported to
the manufacturer and the competent authority.
• Use the test only once. Keep the test upright while testing. Do not move or turn
the test upside down.
• The kit must not be frozen or used after the expiration date printed on the package.
• Components provided in the kit are approved for use in the Vibrio cholerae O1/O139
Combo Rapid Test. Do not use any other commercial kit component.
【STORAGE AND STABILITY】
The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable
through the expiration date printed on the sealed pouch. The test must remain in the
sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
NOTE: It is suggested to use the test within one hour after removing it from the foil
pouch.
【SPECIMEN COLLECTION AND PREPARATION】
• The fecal specimen must be collected in clean, dry, waterproof container containing
no detergents, preservatives or transport media.
• No dietary restrictions are necessary before using the Vibrio cholerae O1/O139
Combo Rapid Test.
• Bring the necessary reagents and feces specimen to room temperature before use.
• If specimens are to be shipped, they should be packed in compliance with local
regulations covering the transportation of etiologic agents.
【MATERIALS】
Materials Provided
Test Cups (with dilution buffer)
Package Insert
Droppers
Materials Required but Not Provided
Timer
Centrifuge
Specimen Container
Pipette
【DIRECTIONS FOR USE】
Before performing the test, allow the test and specimen to reach room
temperature (15-30°C), stool samples must be collected following the instruction
below.
1. Wash your hands with soap and rinse with clear water.
2. 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.
3. Bring the pouch to room temperature before opening it. Remove the test cup from the
foil pouch and use it as soon as possible. Best results will be obtained if the test is
performed immediately after opening the foil pouch.
4. Process fecal specimens:
• For Solid Specimens:
Unscrew the cap of the test cup and take out the specimen collection applicator.
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 specimen (approximately 80 µL) into the test cup containing the dilution
buffer.
5. Insert the specimen collection applicator back into the test cup and tighten the cap.
6. Shake the test cup for about 10-15 seconds to mix well. Leave the cup for reaction for
2 minutes.
7. Remove the plastic limit strip of the test cup.
8. Put the test cup on a clean and level surface, press the cup body from the top to the
bottom and start the timer.
NOTE: Keep the test cup upright during the test developing. Do not move or turn the test
cup upside down.
9. Read results at 10 minutes. Do not read results after 20 minutes.
NOTE: If the specimen does not migrate (presence of particles), open a new test cup,
repeat step 4 and centrifuge the diluted specimen contained in the test cup with a clean
tube. Pipette 1-1.5 mL of supernatant, dispense into the test cup and insert the
specimen collection applicator back into the test cup and tighten the cap. Continue from
step 7-8 onwards in the above instructions for use and start the timer
