A rapid, one step test for the qualitative detection of Human Occult Blood in human feces.
For professional in vitro diagnostic use only.
【INTENDED USE】
The FOB Rapid Test is a lateral flow rapid chromatographic immunoassay for the qualitative
detection of Human Occult Blood in human feces to aid in the diagnosis of gastrointestinal
bleeding.
【SUMMARY】
Many diseases can cause hidden blood in the feces. This is also known as Fecal Occult Blood
(FOB), Human Occult Blood, or Human Hemoglobin. In the early stages of gastrointestinal
problems there may not show any visible symptoms, only occult blood. Traditional
guaiac-based methods lack sensitivity and specificity, and also have diet restrictions prior to
testing.1
The FOB Rapid Test is a rapid test to qualitatively detect low levels of Fecal Occult Blood. The
test uses a double antibody sandwich assay to selectively detect Fecal Occult Blood at
50 ng/mL or 6 μg/g feces. In addition, unlike guaiac assays, the accuracy of the test is not
affected by the diet of the patients.
【PRINCIPLE】
The FOB Rapid Test is a qualitative, lateral flow immunoassay for the detection of Human
Occult Blood in feces. The membrane is precoated with anti-hemoglobin antibody on the test
line region of the test. During testing, the specimen reacts with the particle coated with anti
hemoglobin antibody. The mixture migrates upward on the membrane chromatographically by
capillary action to react with anti-hemoglobin antibody on the membrane and generate a
colored line. The presence of this colored line in the test line region indicates a positive result,
while its absence indicates a negative result. To serve as a procedural control, a colored line
will always appear in the control line region, indicating that the proper volume of specimen has
been added and membrane wicking has occurred.
【REAGENTS】
The test contains anti-hemoglobin antibody particles and anti-hemoglobin antibody coated on
the membrane.
【WARNINGS AND PRECAUTIONS】
Please read all the information in this package insert before performing the test.
• For professional use only. For in vitro diagnostic use only.
• Do not use after expiration date. Do not reuse the test.
• The test should remain in the sealed pouch until use. Do not use test if the pouch is damaged.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Handle all specimens as if they contain infectious agents. Observe established precautions
against microbiological hazards throughout all procedures and follow the standard
procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection
when specimens are assayed.
• Please ensure that an appropriate amount of samples are used for testing. Too much or
too little sample size may lead to deviation of results.
• The used test should be discarded according to local regulations.
• Humidity and temperature may adversely affect results.
• Any serious incident that has occurred in relation to the device shall be reported to the
manufacturer and the competent authority.
【STORAGE AND STABILITY】
The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable through
the expiration date printed on the sealed pouch. The test must remain in the sealed pouch
until use. DO NOT FREEZE. Do not use beyond the expiration date.
Note: It is suggested to use test within one hour after removing it from the foil pouch.
【SPECIMEN COLLECTION AND PREPARATION】
• Specimens should not be collected during or within three days of a menstrual period, or if
the patient suffers from bleeding hemorrhoids or blood in the urine.
• Alcohol, aspirin and other medications taken in excess may cause gastrointestinal irritation
resulting in occult bleeding. Such substances should be discontinued at least 48 hours prior
to testing.
【MATERIALS】
Materials Provided
Test Cups (with dilution buffer)
Package Insert
Materials Required But Not Provided
Specimen Collection Containers
Timer
Pipette
Droppers
【DIRECTIONS FOR USE】
Allow the test, specimen to reach room temperature (15-30°C) prior to testing.
1. To collect fecal specimens:
Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen collection
container. Best results will be obtained if the assay is performed within 6 hours after
collection. Specimen collected may be stored for 3 days at 2-8°C if not tested within 6 hours.
2. To process fecal specimens:
• For Solid Specimens:
Unscrew the cap of the specimen collection tube,then randomly stab the specimen
collection applicator into the fecal specimen in at least 3 different sites to collect
approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.
• For Liquid Specimens:
Hold the dropper vertically, aspirate fecal specimens with a dropper, and then transfer
2 drops of the liquid specimen (approximately 80 μL) into the specimen collection tube
containing the dilution buffer.
3. Insert the specimen collection applicator back into the test cup and tighten the cap.
4. Shake the test cup for about 10-15 seconds to mix well. Leave the cup for reaction for
2 minutes.
5. Remove the plastic limit strip of the test cup.
6. Put the test on a clean and level surface, press the cup body from the top to the bottom and
start the timer.
NOTE: Keep the test upright while testing. Do not move or turn the test upside down.
7. Read results at 5 minutes. Do not read results after 10 minutes.
