Performance Characteristics
1. Accuracy a. The Hb Rapid Test (Feces) The Hb Rapid Test (Feces) has been compared with another leading commercial rapid test using clinical specimens
Relative sensitivity: 98.5% (95%CI*: 95.7%~99.7%);
Relative specificity: 99.7% (95%CI*: 98.2%~99.9%);
Accuracy: 99.2% (95%CI*: 98.0%~99.8%).
*Confidence Intervals
b. The Hb-Hp Complex Rapid Test (Feces) The Hb-Hp Complex Rapid Test (Feces) has been compared with another leading commercial rapid test using clinical specimens.
Relative sensitivity: 96.7% (95%CI*: 82.8%~99.9%);
Relative specificity: 99.0% (95%CI*: 97.1%~99.8%);
Accuracy: 98.8% (95%CI*: 96.9%~99.7%).
*Confidence Intervals
Precision
Intra-Assay
Within-run precision has been determined by using 15 replicates of three specimens: 50ng/ml, 200ng/ml and 2μg/ml positive specimens. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 15 independent assays on the same three specimens: 50ng/ml, 200ng/ml and 2μg/ml positive specimens. Three different lots of the Hb+Hb-Hp Combo Rapid Test Cassette (Feces) have been tested using these specimens. The specimens were correctly identified >99% of the time.
General Description
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. 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.
COA
Publication 
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