Fecal Occult Blood (FOB) Rapid Test

INTENDED USE

The Fecal Occult Blood (FOB) Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human hemoglobin in human stool specimen. This kit is intended for use as an aid in the diagnosis of lower gastrointestinal (g.i.) pathologies.

MATERIALS

Materials Provided

Materials Required but Not provided

TEST PROCEDURE

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

1. 1. Specimen collection and pre-treatment:

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.

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

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. 2. Testing

3. 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.

   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. 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.

   4. INTERPRETATION OF RESULTS
      
      

      POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

      NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

      INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

      NOTE:

      1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
      2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

      3. LIMITATIONS OF THE TEST

         1. 1. The Fecal Occult Blood (FOB) Rapid Testis for professional in vitro diagnostic use, and should only be used for the qualitative detection of human hemoglobin.
         2. 2. The presence of blood in stool specimens may be due to causes other than colorectal bleeding, such as hemorrhoids, blood in urine or stomach irritation.
         3. 3. Negative results do not exclude bleeding since some polyps and colorectal region cancers can bleed intermittently or not at all. Additionally, blood may not be uniformly distributed in fecal samples. Colorectal polyps at an early stage may not bleed.
         4. 4. Urine and excessive dilution of specimens with toilet water may cause erroneous test results.
         5. 5. This test may be exhibit decreased sensitivity for upper gastrointestinal bleeding, as blood degrades as it passes through the gastrointestinal tract.
         6. 6. Not all colorectal bleeding is due to precancerous or cancerous polyps. As with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
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