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RAPID FOB
Registration Number:  №Г004−110−00/3 998 525
A lateral flow immunoassay for qualitative detection of hemoglobin in human feces.
RAPID FOB
Registration Number:  №Г004−110−00/3 998 525
A lateral flow immunoassay for qualitative detection of hemoglobin in human feces.
The Current Diagnostic Landscape
Colorectal cancer (CRC) ranks 2nd in the structure of cancer-related mortality in Russia. Over 70,000 new cases are detected annually, with the risk of developing the disease increasing sharply after the age of 45−50.

The asymptomatic nature of the disease leads to late diagnosis: in 40% of cases, cancer is identified at Stages III-IV, when the prognosis for treatment becomes unfavorable.

Regular screening reduces CRC mortality by 15−33% by detecting occult (hidden) microbleeding characteristic of large polyps and early-stage cancer, enabling the timely initiation of treatment.
01
Immunochemical FOB tests ought not to be specific to the hemoglobin-haptoglobin complex.
The primary objective of such tests is to detect free human hemoglobin, which is released from the lower gastrointestinal tract during bleeding.
02
If a test recognizes the hemoglobin-haptoglobin comple
it creates a high risk of false-positive results caused by blood originating from the upper GI tract or systemic circulation.
Key Advantages
A tool for mass screening of CRC and other lower gastrointestinal diseases
No additional equipment required
Nationwide diagnostic coverage, including remote and hard-to-reach regions
Optimal detection limit — 50 ng/ml
No cross-reactivity with blood from the upper GI tract or systemic circulation
Technical Specifications
Time to Result:
5 minutes
Limit of Detection (LOD):
50 ng/ml
Shelf Life:
28 months
Instructions for use
User manual
Illustrated guide
Interpretation
NEGATIVE RESULT
Appearance in the test window of only the control line “C”. Staining of the test line “T” does not occur.
Positive result
Appearance in the test window of two colored lines: the control line “C” and the test line “T”. The color intensity of the test line may vary. Any degree of color intensity of the test line should be regarded as a positive result.
Invalid result
In the test window, the control line “C” does not appear regardless of the presence of the test line “T”. The cause of an invalid result may be incorrect performance of the analysis procedure or unsuitability of the medical device. In this case, it is recommended to repeat the testing procedure.
Registration certificate
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