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BioSign® iFOB Test

Biosign ifob test

Immunoassay for the Qualitative Detection of Fecal Occult Blood
(Human Hemoglobin in Human Fecal Specimens) as an Aid in
the Diagnosis of Gastrointestinal Disorders

  • Easy-to-read color
  • Built-in test control
  • CLIA Waived
Analytical Detection Limit 50 ng hHb/mL buffer or
50 μg hHb/g feces.
Time to Results 5-10 minutes
Specimen Types Fecal
Internal Control Yes
External Controls No
Storage 2-30°C (35-86°F)
Relative Sensitivity >99.9%
Relative Specificity >99.9%
Overall Accuracy >99.9%
Biosign ifob procedure1 Sample Collection:
  1. Deposit the fecal sample on collection paper or in a clean cup. NOTE: Do not allow collection paper or feces to come into contact with toilet water or urine. The sample should not be tested if it becomes wet or contaminated. If this happens, place a clean tissue on the collection paper, then collect new feces sample for testing. Unscrew the sampler from the collection tube.
  2. With the fecal sample still on collection paper, randomly insert the grooved end of the sampler into the fecal sample in at least 6 different sites. Ensure the grooved end of the sampler is completely covered with fecal sample.
  3. Insert the sampler into the collection tube and firmly tighten it. Do not reopen.
  4. Shake the tube vigorously to mix the sample and the extraction buffer. Note: The extracted fecal sample may be stored at room temperature for up to 10 days.
Sample Application and Result Reading: Biosign ifob procedure2
  1. Shake the collection tube vigorously for 20-30 seconds to ensure the sample is well mixed with the buffer. Some small amount of sample may not dissolve; this is normal.
  2. Remove test device from its foil pouch by tearing at the notch.
  3. Tap the collection tube on a hard surface to dislodge any trapped air in top of cap.
  4. Invert tube several times to ensure all undissolved sample is dispersed in the buffer. Unscrew tip cap on the collection tube. Holding the tube vertically above the sample well of the BioSign® iFOBTest device, squeeze the tube gently to dispense three (3) drops onto the sample well.
  5. Read the result in 5-10 minutes. Important: DO NOT READ RESULTS AFTER 10 MINUTES.
Product Kit Size Catalog Number CLIA Complexity
BioSign® iFOBTest 25 BSP-300-25 Waived