Jase: What does the Prima Bowel FOB Test check for?

Kimmi: Small amounts of blood in a stool sample that may not be visible to the eye.

Jase: Does a result tell you the cause?

Kimmi: No. A positive result needs medical follow-up, and a negative result doesn’t rule out every bowel condition.

Prima Bowel FOB Test is a single-use home screening test for faecal occult blood. Blood in stool can have several causes, including benign and more serious conditions; the test does not diagnose polyps, ulcers, bowel cancer or any other condition. Seek medical advice for a positive result, ongoing symptoms or any visible blood, regardless of the test result, and continue any recommended national bowel-screening programme.

The supplied technical specifications state a detection threshold above 40 ng/mL, specificity of 99%, sensitivity of 78.7% and accuracy of 92.6%. These figures do not guarantee an individual result.

Source-data check: The preserved result text below says positive results may occur between “40 ng/mL and 36 ng/mL”, which is an unclear or reversed range. Follow the enclosed manufacturer instructions rather than relying on that sentence.

Contents:

• 1 test cassette
• 1 vial with collection stick and dropper containing the diluent
• 1 paper sheet for sample collection
• Instructions for use

Directions

USE PROCEDURE

1. Collect the sample using the special collection sheet; 
2. Unscrew the cap of the vial, plunge the withdrawal stick in 3 different points of the sample and screw the cap back on; 
3. 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; 
4. 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. It is recommendable to further check with your doctor. 

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).
 

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