FOB / Gut Health Self-Test for Home Use (Blood in Stool)

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Product Description:

Test yourself for hidden blood in stool (FOB - Fecal Occult Blood) at home in peace and quiet with our fast, CE-marked self-test. With a simple stool sample, you get a reliable result in 5–10 minutes indicating whether you have invisible bleeding in the gastrointestinal tract. Sent in a completely neutral and discreetly packaged envelope directly to your mailbox.

 

How to perform the test in short

  1. Sampling: Collect the stool sample on the provided collection paper. Unscrew the cap of the collection tube and poke the sampling stick into 3 different places in the sample.
  2. Preparation: Insert the stick back into the collection tube, screw the cap tight, and shake vigorously to mix the sample with the dilution buffer. Let the tube stand for 2 minutes.
  3. Reading: Open the cap, turn the tube upside down, and transfer 2 full drops to the specimen well (S) on the test cassette. Read the result at 5 minutes. (Do not interpret the result after 10 minutes have passed).

 

Result interpretation & Important advice

  • Positive result (Two colored lines C and T): Occult (hidden) blood has been detected in the stool. Important: A positive result indicates gastrointestinal bleeding and should always be followed up by a doctor or healthcare center for further medical evaluation.
  • Negative result (One colored line at C): No blood was detected in the stool sample. If you have persistent gastrointestinal symptoms, altered bowel habits, or abdominal pain, you should still consult a physician.
  • Important limitations: Samples should not be collected during menstruation (or within 3 days before/after), if suffering from bleeding hemorrhoids, or if blood is present in urine. Avoid excessive intake of alcohol, aspirin, or anti-inflammatory drugs at least 48 hours prior to testing as they may cause gastrointestinal irritation. No dietary restrictions required.

 

Specifications & Product Information

CE-marked IVD product for self-testing by laypersons according to IVDR (EU) 2017/746

  • Product name: Fecal Occult Blood (FOB) Rapid Test (REF: TFO-N602AH)
  • Risk class (IVDR): Class C
  • Intended purpose: Rapid test for the qualitative detection of occult blood in human stool specimens
  • Detection limit (LOD): 50 ng/mL (or 6 µg/g stool)
  • Results within: 5–10 minutes (do not interpret after 10 minutes)
  • Sample type: Stool sample
  • Performance characteristics:
    • Diagnostic sensitivity: 98.3 %
    • Diagnostic specificity: 98.0 %
    • Overall accuracy: 98.2 %
  • CE marking & Notified body: CE 0123
  • Legal manufacturer: Hangzhou AllTest Biotech Co., Ltd., #550 Yinhai Street, Hangzhou, China
  • EU Authorized Representative: MedNet EC-REP GmbH, Borkstrasse 10, 48163 Muenster, Germany



Item ID:
TFO-N602AH-01

Documents:
attachment Package leaflet (PDF)

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