Bowel FOB Rapid Test

Ref. 800040IP-20P

Rapid immunochromatographic test for the detection of occult blood in the feces. IVD for professional use only.

OCCULT BLOOD IN FECES

The acronym FOB (Fecal Occult Blood) indicates the presence of occult blood in the stool, due to various gastrointestinal disorders such as: polyps, ulcers, colitis, diverticula, rhagades, hemorrhoids or tumor.

The symptoms of these lesions are often silent in the early stages, for this reason the search for occult blood in the feces represents an important screening test that allows to early identify the presence of pathologies affecting the gastrointestinal system.

Benefit of the test

Easy to use

Results in 5 minutes

Rapid support to healthcare personnel

WHO IS THIS TEST FOR?

BOWEL FOB RAPID TEST is useful for identifying the presence of blood in the stool, in some cases not identifiable with the naked eye, especially in people over 45 years of age.

In some cases, the presence of occult blood in the stool is not clearly visible to the naked eye, so it is useful to use devices capable of doing so, without food restrictions before its use.

TECH SPECS

BOWEL FOB RAPID TEST is an immunochromatographic device that detects the smallest amounts (above 40 ng/mL) of occult blood in stool samples.

Cut-off	40 ng/mL
Specificity	99.00%
Sensitivity	78.70%
Accuracy	92.60%

CONTENT

20 test cassettes
20 vials with collection stick and dropper containing the diluent
instructions for use

USE PROCEDURE

Unscrew the cap of the vial, plunge the withdrawal stick in 3 different points of the sample and screw the cap back on;
Break the end of the cap, freeing the dropper part, and dispense 3 drops of the diluted sample into the well (S) indicated on the cassette;
Wait 5 minutes before reading the result.

RESULTS INTERPRETATION

Negative: the presence of occult blood in the feces has not been detected or its concentration is below the reference cut-off.

Positive: the presence of occult blood in the feces has been identified. Positive results can also be obtained in the presence of hemoglobin concentrations between 40 ng/mL and 36 ng/mL. Further diagnostic investigations are recommended.

BIBLIOGRAPHY

1. Van Rossum Leo G. et al.: “Random Comparison of Guaiac and Immunochemical Fecal Occult Blood Tests for colorectal Cancer in a Screening Population” Gastroenterology, Volume 135, Issue 1, 82 – 90.
2. Faivre J., Dancourt V., Denis B., Dorval E., Piette C., Perrin P., Bidan J.M., Jard C., Jung S., Levillain R., Viguier J., Bretagne J.F.: “Comparison between a guaiac and three immunochemical faecal occult blood tests in screening for colorectal cancer”. European Journal of Cancer. 2012; 48(16):2969-76.
3. Benton S.C., Seaman H.E., Halloran S.P.: “Faecal Occult Blood Testing for colorectal Cancer Screening: the past or the Future”. Current Gastroenterology Reports. 2015; 17(2):428
4. European Commission. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First edition 2010

F.A.Q.

What happens if the results reading time is not met?

The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use.

How to prove that the test worked correctly?

A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.

How to interpret the test if the control and test lines have different intensities?

The color and intensity of the lines do not affect the interpretation of the result. The test has to be considered positive regardless of the color intensity of the test line (T).