Debao Biotech

Colorectal cancer is one of the most commonly diagnosed cancers, and a leading cause of cancer death in the United States. Screening for colorectal cancer increases the probability of detecting cancer at an early stage, therefore reducing mortality.

Earlier commercially available FOB tests utilized a guaiac method, which requires special dietary restrictions to minimize false positive and false negative results. Debao Biotech’s FOB Rapid Test Device is especially designed to detect human hemoglobin in fecal samples using immunochemical methods, providing improved specificity for the detection of lower gastrointestinal disorders such as colorectal cancers and adenomas.

Individually pouched test strips	Each test contains colored conjugates and reactive reagents precoated at the corresponding regions.
Specimen collection cards	For specimen collection
Specimen dilution tubes with buffer	Each tube contains 2 mL of 0.1 M phosphate buffered saline (PBS) and 0.02% sodium azide
Package insert	Operating instructions

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

1.Specimen Collection and Pre-Treatment:

a) Use the specimen collection cards provided in the kit. Follow the operating procedure printed on the collection card. For best results, will perform the assay within 6 hours after specimen collection.

b) Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter the solution in the tube. Collect a sample by inserting the applicator stick into at least 3 different sites on the feces specimen.

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

d) 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

a) 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.

b) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and add 3 drops of solution to 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 5 minutes. Do not interpret the result after 10 minutes.