H. Pylori and Transferrini and FOB Rapid Test

Intended Use

H. pylori and Transferrini and FOB Rapid Test (Feces) is a rapid visual immunoassay for the qualitative, presumptive detection of human hemoglobin and transferrin in human fecal specimens.

H. pylori and Transferrini and FOB Rapid Test is intended for use as an aid in the diagnosis of bleeding gastrointestinal disorders.

MATERIALS

● Test devices

● Package insert

● Specimen dilution tubes with buffer

Test Procedure

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Specimen collection and pre-treatment:

1) 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 6 different sites of the feces.

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

3) Shake the specimen collection tube vigorously to mix the specimen and extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.

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. For best results, 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, discard the first two drops of solution and then dispense 3 drops of solution into each 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 5 minutes. Do not interpret the result after 10 minutes.

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