Bleeding in the digestive tract is a symptom of a disease rather than a disease itself. Bleeding can occur as the result of a number of different conditions, some of which are life threatening. Most causes of bleeding are related to conditions that can be cured or controlled, such as ulcers or hemorrhoids. The cause of bleeding may not be serious, but locating the source of bleeding is important. Common causes of occult blood are for ex-ample: esophagitis, gastritis, ulcers, cancer in the gastro intestinal tract (esophagus, sto-mach, colon), hemorrhoids, ulcerative colitis, colorectal polyps, diverticular disease etc. In particular, early detection of colon cancer can significantly improve survival rate.Colorectal Cancer (CRC) detected at an early stage can be successfully treated with surgery. Malignancies and, to a lesser extent, polyps, bleed intermittently as the stool moves past them. Performing an annual fecal occult blood test (FOBT) is one of several recommended options for colorectal cancer screening in the average risk population beginning at age 50. Annual or biennial screening with guaiac-based FOBTs (gFOBT) has been shown in large, randomized trials to have a significant and beneficial effect on colorectal cancer incidence and mortality. However, while the specificity of these tests is generally high, sensitivity is poor. Complicated dietary restrictions prior to testing and sampling instructions may limit patient compliance. Newer, immunochemical FOBTs (iFOBT) are reported to have improved performance characteristics compared to guaiac tests, with no dietary restrictions. 4 Hemoglobin is used by iFOBT and gFOBT as the exclu-sive the blood protein of choice for detecting Occult Blood. The Diagnostik Nord HB-HP Rapid Test detects another blood protein complex: hemoglobin-haptoglobin in addition to Hemoglobin for the detection of occult blood.

The hemoglobin-haptoglobin complex has a higher survival rate within the digestive tract than hemoglobin, thus the dual blood protein detection meaningfully increases the sensitivity of Occult Blood detection, inclu-ding bleeding from upper digestive tract. The colored C-line will always appear if the test has been performed correctly. The test sensitivity for Hb is 50ng/ml and Hb-Hp is 50ng/ml.

 

【DIRECTIONS FOR USE 】

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. To collect fecal specimens:

Collect feces in a clean, dry specimen collection container. Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8°C if not tested within 6 hours.

2. To process fecal specimens:

Unscrew the cap of the specimen collection tube，then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites. Do not scoop the fecal specimen. Screw on and tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the 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.

3. Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.

4. Hold the specimen collection tube upright and open the cap onto the specimen collection tube. Invert the specimen collection tube and transfer 3 full drops of the extracted specimen (approximately 120μL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.

5. Read results at 5 minutes. Do not read results after 10 minutes.