INTENDED USE

The One-Step Fecal Occult Blood (FOB) Diagnostic Kit is a qualitative detection of human occult blood in feces forself-testing.

PRINCIPLE

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.

STORAGE

The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months). Do the test in 1 hour after open the pouch.

WARNING AND PRECAUTIONS

1. For in vitro diagnostic use only.
2. Do not use kit beyond the expiration date.
3. Patient specimens may contain infectious agents and should be handled as though capable of transmitting disease. Wear disposable gloves throughout the specimen collection and assay procedures.
4. The test device should not be reused.

REAGENTS AND MATERIALS PROVIDED

1.  One pouched cassette with desiccant.       

2.  One operating Instruction

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 SAMPLE COLLECTION AND PREPARATION
3. Shake the sample collection device several times.
4. Holding the sample collection device upright, carefully unscrew the tip of collection device.
5. Squeeze 2-3 drops of the sample solution on the test sample pad.
6. Read the test results in 5 minutes.

INTERPRETATION OF RESULTS

Negative: Only one colored band appears on the control region (C). No colored band in the test region (T).

Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).

Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test device.

LIMITATION

1. The test is a qualitative screening assay for determination of human occult blood in feces and is not for determining quantitative concentration levels.
2. Positive result can only indicate that hemoglobin occurred in human feces. Hemorrhoids, gastric ulcer and menses bleeding or interfere by hemo urine also may cause a positive result.
3. Colonic bleeding is not caused by cancer or pathological changes before cancer totally. Please confirm the result with professional doctor.