FOB Rapid Test

PocTell^® FOB Rapid Test Device is a rapid visual immunoassay for the qualitative presumptive detection of human hemoglobin in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of lower gastrointestinal (g.i.) pathologies.

PocTell^® FOB Rapid Test Device (Feces) has been designed to detect human hemoglobin through visual interpretation of color development in the internal strip. The membrane was immobilized with anti-human hemoglobin antibodies on the test region. During the test, the specimen is allowed to react with colored anti-human hemoglobin antibodies colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough human hemoglobin in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred..

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

1. Specimen collection and pre-treatment:

1)Use the specimen collection container for specimen collection. Best results will be obtained if the assay is performed within 4 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)Place 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. Specimens prepared in the specimen collection tube should be tested in 1 hour after preparation.

2. Testing

1)Remove the test from its sealed pouch, and place it on a clean, level surface.

2)Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2-3 drops of solution (about 80 μL to 120 μL) into the specimen well (S) of the test device. Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.

As the test begins to work, you will see color move 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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