BIONEXIA® FOBplus

Early detection of colorectal cancer

The BIONEXIA® FOBplus rapid test is a non-invasive method for colorectal cancer screening.

  • Very sensitive Fecal Occult Blood test
  • Results available at just 5 minutes
  • User-friendly method for increased patient comfort and easy interpretation
Add to your selection

Do you need more information

Colorectal cancer is one of the most common causes of death from cancer. However, if it is detected at a very early stage, there is an over 90% chance of survival. Adenomatous polyps, that have the potential to transform into cancer, tend to bleed frequently. It is known that their early removal reduces the risk of colorectal cancer1.

The BIONEXIA® FOBplus rapid test allows the detection in stools of human hemoglobin potentially linked to adenomatous polyps. Without automatically pointing to cancer, a positive test result indicates a disorder which should be investigated further.

High sensitivity

The BIONEXIA® FOBplus test is much more sensitive than Guaiac-based tests2 in correlation with clinical diagnosis.

Diagnostic sensitivity

  BIONEXIA® FOBplus Guaiac-based FOBT
Clinical Diagnosis Positive results Sensitivity %
(95%CI*)
Positive results Sensitivity %
(95%CI*)
Advanced adenoma 68/130 52.3 (43.4-61.1) 12/128 9.4 (4.9-15.8)
Other adenoma 77/275 28.0 (22.8-33.7) 9/260 3.5 (1.6-6.5)
Any adenoma 145/405 35.8 (31.1-40.7) 21/388 5.4 (3.4-8.2)

*Confidence interval
The performance characteristics were assessed on a target population for screening. The sensitivity of the BIONEXIA® FOBplus test for the detection of all adenomas is 35.8%, and for the Guaiac-based FOBT it is 5.4%

Diagnostic specificity

  BIONEXIA® FOBplus Guaiac-based FOBT
Clinical diagnosis Negative results Specificity %
(95%CI*)
Negative results Specificity %
(95%CI*)
None or hyperplastic polyp 749/914 81.9
(79.3-84.4)
851/887 95.9
(94.4-97.1)

The specificity of the BIONEXIA® FOBplus test is 81.9% for patients with a negative colonoscopy.
 

Easy-to-read results


 

2 red bands = positive*; 1 red control band = negative.

*A positive FOB test should always be followed-up by further investigations, such as colonoscopy.

Increased patient comfort

  • Patient set: biodegradable stool collection paper, sample tube
  • Simple, “no mess” collection kit with clear instructions for use
  • Single stool collection
  • No special diet required before testing
  • No reaction with non-steroidal anti-inflammatory drugs

References:

1. Atkin WS, Edwards R, Kralj-Hans I, et al. Lancet 2010;375(9726):1624-33.

2. Hundt S et al. Comparative Evaluation of Immunochemical Fecal Occult Blood Tests for Colorectal Adenoma Detection. Ann Intern Med. 2009; 150:162-169.

BIONEXIA® FOBplus / All-inclusive kit
Reference 410594
Contents - 25 test cassettes
- 25 patient sets, including stool paper, sample tube and instructions
Sample type Stools
Analytical sensitivity 40 ng/ml
Time to result 5 minutes
Sample volume 4 drops of sample extract
Storage temperature + 2 to + 30°C
Shelf life 24 months from date of manufacturing

 

BIONEXIA® FOBplus LK / Lab Kit
Reference 414275
Contents -25 test cassettes
-25 sample tubes
Sample type Stools
Analytical sensitivity 40 ng/ml
Time to result 5 minutes
Sample volume 4 drops of sample extract
Storage temperature + 2 to + 30°C
Shelf life 24 months from date of manufacturing

 

BIONEXIA® FOBplus PS / Patient Set
Reference 414276
Contents 25 patient sets, including stool paper, sample tube and instructions

 

Consult your local bioMérieux representative for product availability in your country.

Please consult your local bioMérieux representative for product availability in your country

Pioneering diagnostics