【INTENDED USE】

The FOB Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Human Occult Blood in feces.

【SUMMARY】

Many diseases can cause hidden blood in the feces. This is also known as FOB (FOB),Human Occult Blood,or Human Hemoglobin.In the early stages,gastrointestinal problems such as colon cancer,ulcers,polyps,colitis,diverticulitis,and fissures 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.1,2

The FOB Rapid Test Device  is a rapid test to qualitatively detect low levels of FOB.The test uses a double antibody sandwich assay to selectively detect FOB at 75ng/mL or higher,or 6 µg/g feces. In addition,unlike guaiac assays,the accuracy of the test is not affected by the diet of the patients.

【DIRECTIONS FOR USE 】

Allow test,specimen collection tube,specimen,and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. To collect fecal specimens:

Collect feces 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.

*NOTE:Considering the unexpected substances and/or microorganisms exist in feces may affect the stability of hemoglobin,it’s best to test the feces as soon as possible.

2. To process fecal specimens:

Unscrew the whole cap of the specimen collection tube,then randomly stab the specimen collection stick into the fecal specimen in at least 3 different sites.Do not scoop the fecal specimen.

Screw on and tighten the cap onto the specimen collection tube,then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.Specimens prepared in the specimen collection tube may be stored for 3 days at room temperature (15-30°C) if not tested within 1 hour after preparation.

3. Remove the test device from the sealed pouch and use it as soon as possible. Do not touch the membrane of the strip.

4. Hold the specimen collection tube upright and then unscrew and open the upper cap. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approx.80mL) to the specimen well (S) of the test device, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.

5. Wait for the colored line(s) to appear.Read results at 8 minutes.Do not interpret the result after 20 minutes.