Faecal occult blood test

Information about the home faecal immunochemical test myCARE® Colon Polyps Test

The home faecal immunochemical test for the detection of occult (hidden) blood in stool is a medical diagnostic device for self-testing.

The test accurately detects only human haemoglobin in faeces which is a notable improvement over conventional faecal occult blood tests.

Testing with this faecal immunochemical test (iFOB test) is quick and very easy. You carry out the analysis in three steps:

1. Collect a small sample of stool.
2. Mix the stool sample with a buffer solution into suspension.
3. Add suspension to the testing device and wait 5 minutes for the result.

Individuals who never performed the test before usually need between 3-5 minutes to complete the faecal occult blood test at home. There is an additional 5-minute waiting time for the result to appear.

The Colon polyps test is manufactured in Austria. It is ISO 13485 compliant and certified in Germany by the Notification body CE0483¹.

This faecal occult blood test is very accurate and reliable. In a clinical trial, this iFOB test detected 91 % of all cancer cases.

You will receive the iFOB testing kit at home in discreet packaging so that nobody will know what is inside the package.

The faecal occult blood test comes with the Sanotest Quality Guarantee and will be replaced to you free of charge in case you were not able to obtain the result.

Blood in stool and bowel cancer

Bowel cancer is the third most common cancer in the world among men and the second most common cancer among women.²

In western countries, bowel cancer is responsible for approximately 10 % of deaths due to disease.³

Expert estimate that the incidence of bowel cancer will increase by 60 % by the year 2030.⁴

In the UK, there are 42,000 new bowel cancer cases every year, and 54 % of bowel cancer cases are preventable.⁵

To the incidence of bowel cancer contribute ageing population, inadequate eating habits and risk factors such as smoking, lack of physical activity and obesity.⁶

Faecal occult blood is an early clinical sign of potentially severe problems of digestion tract like colon polyps. Colon polyps can advance in bowel cancer. Therefore medical experts recommend to carry out testing for the blood in stool regularly.

Screening for bowel cancer at home

The faecal occult blood test enables you to check if there is occult blood in the stool.

Traces of blood in stool are a sign of internal bleeding and can mean the presence of polyps in the colon. From these polyps, bowel cancer can develop.

It is vital to regularly screen for signs of bowel cancer, and this faecal occult blood test can be of great help.

Main advantages of this test are that it detects specifically human blood and no other types of blood and that you can perform the occult blood check by yourself at home.

If you are experiencing digestive problems, it might be beneficial that you also do a Helicobacter pylori test, Coeliac disease test, Milk allergy test or Egg allergy test.

When to screen for bowel cancer?

Risk of developing bowel cancer increases with age⁷ and is influenced by several risk factors. Although in majority cases a bowel cancer develops in people over 50 years old, it can also develop in a younger population.

Cancer Research UK on their website thoroughly explains risk factors for bowel cancer such as diet, smoking, alcohol, physical inactivity etc.

Symptoms and signs of bowel cancer are often not apparent until the disease advances already. It is essential to pay attention to any unexplained changes in bowel habits and consult a doctor if such changes persist.

To individuals aged 60 to 74, we recommend to take the opportunity and get tested within the UK national bowel cancer screening programme.

Experts recommend regular screening for bowel cancer to individuals over 50, but younger as well, especially to those in groups with a higher risk of developing bowel cancer, such as⁸:

• close relatives of patients who developed bowel cancer before the age of 60 (father, mother, brother, sister),
• patients with chronic inflammatory bowel disease,
• patients who already have had colon polyps.

How to perform the faecal occult blood test at home?

A unique design of the test enables individuals with no knowledge or experience in medical self-testing to carry out the analysis easily by themselves at home.

Testing with this faecal immunochemical test (iFOB test) is quick and very easy. You carry out the analysis in three steps:

1. Collect a small sample of stool.
2. Mix the stool sample with a buffer solution into suspension.
3. Add suspension to the testing device and wait 5 minutes for the result.

Individuals who never performed the test before usually need between 3-5 minutes to complete the faecal occult blood test at home. There is an additional 5-minute waiting time for the result to appear.

You should read instructions for use before you start the testing procedure. Individuals usually do not have difficulties in performing testing by themselves at home. Still, in case you find it difficult, we are at your disposal for any questions you might have. Contact our customer service.

How accurate is the home faecal immunochemical test?

In a clinical trial, this home immunochemical faecal occult blood test detected 91 % of all cancer cases what makes the test very accurate and highly reliable. In a clinical trial with 646 participants, this iFOB test showed 94% specificity and 99% sensitivity for colorectal carcinomas.

The test detects explicitly only human haemoglobin in faeces, which is a significant advantage over conventional faecal blood tests on the market that also detect other than human blood in the stool (e. g. blood from food).

The test is of trusted origin. It is manufactured in Austria, it is ISO 13485 compliant and certified in Germany by the Notification body CE0483⁹.

The usefulness of the results obtained with the home faecal immunochemical test

Results obtained with a home immunochemical faecal occult blood test are beneficial at screening efforts for bowel cancer.

The sooner the faecal occult blood as a sign of colon polyps and potential bowel cancer is discovered, the better are chances of successful treatment in case of developing the disease.

Results are interpreted visually as positive, negative or invalid.

In case of a positive result: the blood is detected in your stool. You should consult with your doctor about further steps

Important notice: blood in stool does not necessarily mean that you have bowel cancer.

In case of a negative result: no blood is detected in your stool. Anyway, you should always pay attention to any unexplained changes in bowel habits. If symptoms repeat, it might be beneficial to perform another test. If symptoms persist, you should consult your doctor for further investigation.

In case of an invalid result: Take a picture of the result and contact us.

Limitations of the home immunochemical faecal occult blood test

With many advantages of the faecal occult blood test (iFOB test), there are also some limitations you should consider before ordering the test.

The iFOB test does not detect bowel cancer.

The test is an immunological test for detection of the human haemoglobin in the stool. The test does not detect bowel cancer directly, but the blood in stool that is the most common sign of colon polyps that can advance into bowel cancer.

The iFOB test is for single use and one person only.

You should never combine faeces sample of different individuals or reuse the test. Only one person should use the test, and when you complete it, you cannot reuse it.

Women only: You must not perform the iFOB test during or for up to 3 days after a period.

If you have menstrual bleeding, you should not use the test. The test detects blood and will lead to possible false-positive results.

You should not establish a diagnosis on your own and solely based on this iFOB test.

Although the test is highly accurate, you should not establish a diagnosis and conclusions about the treatment solely based on the result of this test. Results of the test should be assessed in light of other available clinical information.

Please note that blood in stool does not necessarily mean that you have bowel cancer. You should always consult your doctor for further investigation, diagnosis, and potential treatment.

Questions and answers about the home faecal immunochemical test

In the following are summarized questions individuals frequently ask us about the faecal occult blood test or testing at home. Perhaps you find the answers useful.

If you have other questions, do not hesitate to contact us. Please send us your question by email at self-testing@sanotest.co.uk

Do I need to follow any particular diet before checking the presence of blood in stool with this test?

No, you do not need to follow any diet prior testing. The faecal immunochemical home test detects specifically human haemoglobin; therefore, blood from food (e.g. meat) will not affect the result of the test.

Are there any substances known to affect the result of the test?

Alcohol and several medicines such as acetylsalicylic acid (aspirin), glucocorticoids, non-steroidal antiphlogistic / anti-rheumatic agents or coumarin derivates can cause internal bleeding; therefore, false-positive results.

How do you know that a testing device works correctly?

A testing device has an internal control integrated. When a colour line appears in the control area of a testing device, it means that a testing device works correctly.

Can I perform the test if I have diarrhoea?

We recommend to regulate your bowel movement first and the carry out the test. Moreover, the stool you need to sample should not come into contact with toilet water. Therefore it is better to wait until the stool is back in a healthy state. If diarrhoea persists, we recommend you to consult a doctor.

Literature:

¹ European Commission. Tools and Databases, Legislation. Accessible at: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&refe_cd=EPOS_43805 (10. 03. 2020).
² World Health Organization, International Agency for Research on Cancer. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Accessible at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx (24. 7. 2018).
³ Kuipers J. E., et. Al, 2015. Colorectal cancer. Nature Reviews Disease Primers, 2015(1), 15065.
⁴ Arnold M. et la., 2015. Global patterns and trends in colorectal cancer incidence and mortality. Gut 2016(0), 1–9.
⁵ Cancer Research UK. Bowel cancer statistics. Accessible at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bowel-cancer#heading-Five (21. 2. 2020)
⁶ Kuipers J. E., et. Al, 2015. Colorectal cancer. Nature Reviews Disease Primers, 2015(1), 15065.
⁷ Cancer Research UK. Bowel cancer screening: The facts. Accessible at: https://www.buckshealthcare.nhs.uk/Downloads/cancer/Bowel-cancer-screening-programme-the-facts.pdf (22. 02. 2020)
⁸ Centers for Disease Control and Prevention. Colorectal (Colon) Cancer. What should I know about screening? Accessible at: https://www.cdc.gov/cancer/colorectal/basic_info/screening/index.htm (22. 02. 2020)
⁹ European Commission. Tools and Databases, Legislation. Accessible at: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&refe_cd=EPOS_43805 (10. 03. 2020).