The HEMDETECT IMMO - FOB Test is a qualitative, lateral flow immunoassay for the detection of human occult blood in feces.
The membrane is pre-coated with antihemoglobin antibody on the test line region of the device. During testing, the specimen reacts with the particle coated with anti-hemoglobin antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with antihemoglobin antibody on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occured.
The HEMDETECT® Test is based on a modified guaiac method for detecting occult blood. If developer solution (stabilized hydrogen peroxide 4% in denatured ethanol 60%) is applied to the test field of the HEMDETECT® Test, a blue colour indicates the presence of haemoglobin. If the result is positive, further tests are necessary in order to determine the cause of the haemorrhage. The HEMDETECT® guaiac test is a conventional, reasonably priced and aesthetic method for taking, storing and transporting stool samples to be tested for occult blood. Guaiac tests cannot provide definitive proof either for the presence or for the absence of gastrointestinal haemorrhage or pathological processes. False positives or false negatives can occur as a result of failing to keep to the diet or of taking medication (see PREPARING OF THE PATIENT). This test is conceived as a preventive medical examination and not as a replacement for other diagnostic methods such as sigmoidoscopy, barium enema or X-ray methods.