Hemosure® One Step Immunological Fecal Occult Blood Test is a qualitative, sandwich dye conjugate immunoassay and employs a unique combination of monoclonal and polyclonal antibodies to selectively identify hemoglobin in test samples with a high degree of sensitivity.
In less than five minutes, elevated levels of human hemoglobin (hHb) as low as 50ng hHb/mL can be detected and positive results for high levels of hemoglobin can be seen in the test as early as two to three minutes. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to antihemoglobin antibody in the positive test reaction zone and produces a pink-rose color band. In the absence of hemoglobin, there is no line in the positive test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly.
- FDA 510K Cleared and CLIA Waived
- No drugs or dietary restrictions.
- Non-invasive; take home collection kit (test in the privacy of your home).
- More sanitary and easier to use (step-by-step instructions included).
- Reduces false positives & false negatives.
- Lower GI analytical specificity and sensitivity detects as low as 50ng hHB/mL (specific to human hemoglobin).
- Improved patient compliance.
- 40% more collection tubes and home kit mailers with our best selling kit (T1-CK30).
- Greater reimbursement - $21.82 vs. $4.46
- Ease of use; includes patient instructions (available in multiple languages).
- Reduces foul odors and handling messy unsanitary stool cards.
- Easy to read test result at 5 minutes.