One-Step Fecal Occult Blood (FOB)

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NewScen Coast Bio-Pharmaceutical Co., Ltd

Business Type:Manufacturer

Country/Region:China

Ddu Verified

HOT Rank

6/10

Product Information

  • Certification:CE
  • Brand Name:NewScen
  • Trademark:NewScen
  • Place of Origin:Tianjin
  • Warranty:2 years

Description

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.

STORAGE
The kits should be stored at temperature 4-30°C the sealed pouch for the duration of the shelf life (24months).

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 nagative.
4. If both the Immune Colloidal Method and Chemical Method show nagative ,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.


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