1. Specimen collection and pre-treatment:

1)Use clean, dry containers for specimen collection. Best results will be obtained if the assay is performed within 6 hours after collection.

2)Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).

3)Replace the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.

4)Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.

2. Testing

1)Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within one hour.

2)Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 3 drops of solution into the specimen well (S) of the test device.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area. As the test begins to work, color will migrate across the membrane.

3)Wait for the colored band(s) to appear. The result should be read at 10minutes. Do not interpret the result after 20 minutes. Note: If the specimen does not migrate due to the presence of particles, centrifuge the extracted specimens contained in the extraction buffer vial. Collect 100 μL of supernatant, dispense into the specimen well (S) of a new test device and start again, following the instructions described above.