One-Step Fecal Occult Blood (FOB) Diagnostic Kit (immuno/chemistry)
Main Features
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Simple:
No Instrument Required
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Convenient:
Room Temperature Storage
Built-in Control
Self-test at home
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Fast:
Results in 5-30 minutes
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Strong positive results can be observed
Promptly within 3 minutes
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Reliable:
Accuracy higher than 98%
Early detection of the presence of FOB
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Use of patented immunological and chemical test technique combined to give reliable results
Patented technology, superior quality
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Intended Use
The One-Step Fecal Occult Blood (FOB) Diagnostic Kit is a qualitative detection of human occult blood in feces for self-testing.
Principle
Immune Colloidal Gold Method: The One-Step Fecal Occult Blood (FOB) Diagnostic Kit is an immunochromatographic sandwich method, which employ two specific monoclonal 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 200ng/ml hemoglobin in feces. In addition, the accuracy of the test is not affected by interfering substances, and dietary restriction is not necessary.
Chemical Method: Hemoglobin has peroxidase activity which can cause peroxide decompose then release oxygen atom. The oxygen atom oxidizes 3, 3’, 5, 5’-tetramethyl-benzidine indicator to change the color. When the sample has human hemoglobin, the resulting colors range from orange to yellow-green or dark green. Very high blood concentration may cause the color development to continue to dark blue.
Sample Collection and Preparation
1. Collect stool sample by using the sample collection device provided.
2. Unscrew the top of the sample collection device, take out the sample collection stick, and collect the sample by dipping the stick into 3 different places of the stool sample.
3. Put the sample collection stick back in the sample collection device and screw together tightly.
4. If the sample cannot be tested on the day of collection, store the stool sample at 4°C. Bring the specimen to room temperature before testing.
Assay Procedure
1. Remove the test device from foil pouch by tearing along the notch.
2. Specimen collection. Please see also SPECIMEN COLLECTION
3. Shake the sample collection device several times.
4. Holding the sample collection device upright, carefully screw off the cap of collection device.
5. Squeeze 2-3 drops of the sample solution on the test sample pad.
6. Read the Chemical Method result through the sample pad in 1 minute and read the Immune Colloidal Method result through the result window in 5 minutes.
7. Get the final result according to the synthetically.
Interpretation of Results
Interpretation of Immune Collodial Method:
1. Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).
2. Negative: Only one colored band appears on the control region (C). No colored band in the test region (T).
3. Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test device.
Interpretation of Chemical Method:
1. Positive: The color of the sample pad changes from orange to yellow-green or dark green in 1 minute after adding the sample.
2. Negative: There is no color change of the sample pad in 1 minute after adding the sample.
3. Invalid: If the color mixed, the test should be repeated using a new test device.
The final interpretation:
1. If both the Immune Colloidal Method and Chemical Method show positive, the final result is positive which indicates bleeding in specimen.
2. If the Immune Colloidal Method shows positive while Chemical Method shows negative, this indicates occult bleeding. The concentration of hemoglobin in the sample is much lower. The final result is also positive.
3. If the Immune Colloidal Method shows negative while Chemical Method shows positive, this probably because the high concentration of hemoglobin causing antigen excess, and have hook effect. It is suggested that dilute the sample 100 times and retest, if Immune Colloidal Method shows positive, this indicates the enteron begin to bleed profusely; if Immune Colloidal Method still shows negative, this indicates some substances interfered, the result should be negative.
4. If both the Immune Colloidal Method and Chemical Method show negative ,the final result is nagative.
5. If any one of Immune Colloidal Method and Chemical Method shows invalid, the test result is invalid, please retest with a new one.
Storage
The kits should be stored at temperature 4-30°C the sealed pouch for the duration of the shelf life (24months).
Performance Characteristics
Analytic Sensitivity: 0.2μg/mL for Immune Colloidal Method; 2μg/mL for Chemical Method Analytic Specificity: For Immune Colloidal Method, 0.5mg/mL hemoglobin solution of pig, beef, sheep, dog, chicken and rabbit; 2mg/mL horse radish peroxidase sample; water and sample diluent were shown not to interfere with FOB test by Immune Colloidal Method.
There is no cross react with water and sample diluent for Chemical Method. The 1.66μmol/L acetaminophen, 206μmol/L amoxicillin, 227μmol/L ascorbic acid, and 26.1μmol/L para-aminosalicylic acid were shown not to interfere with FOB test.
Limitation
1. Specimen collection should not be performed during or within three days of a menstrual period, or if the patient suffers from bleeding hemorrhoids or blood in the urine, false-positive test results may be obtained.
2. If the subjects ate meat, pluck or chalybeate food within 3 days, the Chemical Method test result may shows positive. Please pay attention to the result and confirm again.
3. Interference substance in the samples or failed operation may cause false result. Please retest with a new one or use other way to confirm.
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