FOB TEST INTENDED USE
The One-Step Fecal Occult Blood (FOB) Diagnostic Kit is a qualitative detection of human occult blood
in feces forself-testing.
FOB TEST 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.
FOB TEST 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
- For in vitro diagnostic use only.
- Do not use kit beyond the expiration date.
- 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.
- The test device should not be reused.
REAGENTS AND MATERIALS PROVIDED
1. One pouched cassette with desiccant.
2. One operating Instruction
MATERIALS REQUIRED BUT NOT PROVIDED
1. Clock or Timer
SPECIMEN COLLECTION AND PREPARATION
- Collect stool sample by using the sample collection device
- 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.
- Put the sample collection stick back in the sample collection
device and screw together tightly.
- 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
FOB TEST ASSAY PROCEDURE
- Remove the test device from foil pouch by tearing along the notch.
- Specimen collection. Please see also SAMPLE COLLECTION AND
- Shake the sample collection device several times.
- Holding the sample collection device upright, carefully unscrew the
tip of collection device.
- Squeeze 2-3 drops of the sample solution on the test sample pad.
- 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.
FOB TEST LIMITATION
- The test is a qualitative screening assay for determination of
human occult blood in feces and is not for determining quantitative
- 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.
- Colonic bleeding is not caused by cancer or pathological changes
before cancer totally. Please confirm the result with professional
Contact Rebecca Yan