DIRECTIONS FOR USE
Allow the test cassette, specimen, buffer, and/or controls to equilibrate to room temperature (15-30 °C) prior to testing.
1. Collect sufficient quantity of feces (1-2mL or 1-2g) in a clean, dry specimen collection container to obtain enough pathogens. 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.
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 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 specimen
collection tube containing the extraction buffer. Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the collection tube for reaction for 2 minutes.
2. Bring the pouch to room temperature before opening it. Remove the test cassette 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.
3. Hold the specimen collection tube upright and unscrew the tip of the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80 µL) 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.
4. Read the 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 diluted sample contained in the extraction buffer vial. Collect 160 µL
of supernatant, dispense into the specimen well (S) of a new test cassette and start afresh following the instructions mentioned above.
INTERPRETATION OF RESULTS
Positive: The presence of both C line and T line, regardless of T line being strong or faint.
Negative: Only clear C line appears.
Invalid: No colored line appears in C zone, regardless of T line’s appearance.
