Accurate FOB diagnostic rapid test - INC-413

Accurate FOB diagnostic rapid test

Fecal Occult Blood(FOB) best double rapid Test is qualitative test for the detection of human blood hemoglobin in human stool specimens and early diagnosis for Colon Cancer by Fecal Occult Blood screening with double methods, immunology and chemistry
General Information for Fecal Occult Blood(FOB) best double rapid Test

No Cross reactivity :(Bovine, Hemoglobin, Swine hemoglobin, Horse hemoglobin, Bililrubin, Bovine serum albumin, Vitamin C)
Analytical sensitivity : 20ng/ml of FOB (immunology) ,100ng/ml of FOB (chemistry)

Procedure

SPECIMEN 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 break off the tip 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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