Fecal occult blood kit


Fecal Occult Blood Test Kit (Chemical +Double Antibody Sandwich Method)
FOB
Clinical Significance
FOB Test is a rapid, visual immunochromatographic test for the qualitative detection of blood hemoglobin in fecal samples. The main use for the fecal occult blood test (FOB test) is as a screen for early colon cancer. Blood in the stool may be the only symptom of early cancer lf detected early; treatment can begin immediately, improving the chance of a cure.

Fecal Occult Blood Test Kit (Chemical +Double Antibody Sandwich Method)
FOB
Clinical Significance
FOB Test is a rapid, visual immunochromatographic test for the qualitative detection of blood hemoglobin in fecal samples. The main use for the fecal occult blood test (FOB test) is as a screen for early colon cancer. Blood in the stool may be the only symptom of early cancer lf detected early; treatment can begin immediately, improving the chance of a cure.
Why is fecal occult blood testing done?
A fecal occult blood test is done primarily to detect or prevent colon cancer in people without intestinal symptoms. Cancers of the colon are common and frequently produce fecal occult blood long before they cause other symptoms such as abdominal pain, rectal bleeding, or changes in bowel habits. In addition, some precursors of colon cancer, specifically, some types of colon polyps also may bleed slowly and cause fecal occult blood. By finding the cancers early through fecal occult blood testing when the cancers are small and before they metastasize (spread to distant organs), patients may be cured of their cancers by removing them surgically. By removing precancerous polyps that are found through fecal occult blood testing, cancer may be prevented.
Main Features
(1) One Step FOB (Fecal Occult Blood) rapid test is a rapid direct binding test for the detection of Gastroenteric Bleeding in Feces
(2) Format: strip or cassette
(3) Specification: strip (3.0mm), cassette (3.0mm. 4.0mm), or according to the customer’s requirements
(4) Specimen: serum, plasma, whole blood
(5) Design: according to the customer’s requirements
(6) Sensitivity: 100NG/ML, Specificity: over 99%
(7) Long shelf life: 24 months at room temperature
(8)Packing details: 1 set/bag, 5000sets/ctn, 1,300,000sets/20ft container; cassette/midstream: 1 set/bag, 2000sets/ctn, 500,000sets/20ft container
Test Principle
1) Immunochemical methods using a haemoglobin specific cassette or strip test
The test principle is an immunochromatographic sandwich method, which employ specific polyclonal antibodies to selectively identify hemoglobin in test samples. The result is very specific, and easier to interpret than those of guaiac-based test. The sensitivity is very high with the ability to detect 0.2μg /ml hemoglobin in feces. In addition, the accuracy of the test is not affected by interfering substances, and dietary restriction is not necessary.
Test Procedures
1)the patient sample is removed from the collection card, and the sample is mixed with buffer. The buffer solution is then introduced into a test device which contains polyclonal antibodies. The buffer solution will migrate through the test device for a specific amount of time, usually 5 minutes, and a colored line will develop at the “T” if the test sample contains human hemoglobin.
2) Chemical Methods using guaiac based reagents prepared in the laboratory.
The principle of chemical tests to detect occult blood is based on the fact that hemoglobin and its derivatives react in a similar way to peroxidase enzymes– by catalyzing the transfer of an oxygen atom from the peroxide to a chromogen such as benzidine, o-toludine, guaiac or aminophenazone. Oxidation of the chromogen is indicated by the production of a blue, blue-green or pink color. A simplified reaction equation is shown below:
Test Procedures
2) Chemical Methods using guaiac based reagents prepared in the laboratory.
The principle of chemical tests to detect occult blood is based on the fact that hemoglobin and its derivatives react in a similar way to peroxidase enzymes– by catalyzing the transfer of an oxygen atom from the peroxide to a chromogen such as benzidine, o-toludine, guaiac or aminophenazone. Oxidation of the chromogen is indicated by the production of a blue, blue-green or pink color. A simplified reaction equation is shown below:
Procedures

1)In these types of test, a sample of the patient’s stool is placed on a special collection card and returned to the lab. The portion of the collection card containing the patient sample is removed from the collection card, and the sample is mixed with buffer. The buffer solution is then introduced into a test device which contains polyclonal antibodies. The buffer solution will migrate through the test device for a specific amount of time, usually 5 minutes, and a colored line will develop at the “T” if the test sample contains human hemoglobin.
2) Chemical Methods using guaiac based reagents prepared in the laboratory.
The principle of chemical tests to detect occult blood is based on the fact that hemoglobin and its derivatives react in a similar way to peroxidase enzymes– by catalyzing the transfer of an oxygen atom from the peroxide to a chromogen such as benzidine, o-toludine, guaiac or aminophenazone. Oxidation of the chromogen is indicated by the production of a blue, blue-green or pink color. A simplified reaction equation is shown below:

Test Procedures

The test is performed on a paper slide that contains paper sqaures coated with guaiac, a chemical derived from tree resin. A small portion of stool (fecal) specimen is applied to the paper. A developer solution containing hydrogen peroxide (H2O2) is added to the paper. If the blood is present in the specimen, the iron (Fe) in the hemoglobin catalyses the reaction between guaiac in the paper and the H2O2. The completed reaction forms a blue color.
Interpretation of Assay Result
Positive: In addition to a colored control band, a distinct colored band will also appear in the test region.
Negative: Only one colored band appear on the control region. No apparent band on the test region.
Invalid: A total absence of colored line in both (T) and (C) regions or no colored line appears on the control (C) region. The test failed, or the test procedure was not followed properly. Verify the test procedure and repeat the test with a new testing device.
Precautions
1. For in vitro diagnostic use only.
2. Do not use test kit after expiry date.
3. The test device should not be reused.
4. Keep out of the reach of children.
5. Patient specimens may contain infectious agents and should be handled as though capable of transmitting disease.
Storage and Stability
1. The test kit is to be stored at room temperature 4~30°Cin the sealed pouch.
2. The shelf life is 18 months.
3. Keep away from direct sunlight, moisture and heat. Avoid freezing and thawing repeated

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