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Taking steps towards harmonisation of screening tests for colorectal cancer

Taking steps towards standardisation of screening tests for colorectal cancer
Jul 20 2018

The JRC, in close collaboration with the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC), has embarked on standardisation activities related to the screening of colorectal cancer using Faecal Immunochemical Testing (FIT). The work aims at the comparability of testing results regardless of which tests are used in national screening programmes.

Colorectal cancer is the second most common cause of cancer death in Europe. However, when diagnosed at an early stage, the disease can be treated with a survival rate of around 90-95%.

Many large-scale screening programmes for colorectal cancer are based on Faecal Immunochemical Testing (FIT).

Colorectal cancers and pre-cancerous polyps can easily bleed leading to (non-visible) traces of blood in the stool. FIT can detect these traces by measuring the amount of the human haemoglobin protein present in red blood cells. If the result of a test is positive, a colonoscopy is advised to determine whether there is a tumour or a polyp present. It has been proven that when combined with a colonoscopy, FIT screening programmes can lower the mortality rate of colorectal cancer.

FIT is considered to be a suitable screening test because it is easy to perform at relatively low costs, but the test can give false positive and false negative results for various reasons. Some reasons are not linked to the tests themselves, e.g. not all cancers bleed, or haemoglobin can be present for other reasons than cancer. Other reasons could be solved by optimisation of the pre-analytical steps (i.e. the sampling – it should be noted that the individuals usually do the sampling - and the storage conditions) or by standardisation of the haemoglobin measurement. Measurement standardisation is particularly important as the tests are used in extensive screening programmes, and small shifts in the results can have a significant impact on the number of people undergoing colonoscopy.

As the JRC will kick-off the European Commission Initiative on Colorectal Cancer (ECICC) soon, it had already convinced the IFCC in 2017 to create a specific working group on FIT. This group includes representatives from laboratories organising colorectal cancer screenings, diagnostic laboratories, research groups, manufacturers of FIT devices, organisers of external quality assessment schemes and scientists of the JRC. The standardisation of the pre-analytical phase and the haemoglobin measurement are two of the main topics of the working group.

The JRC provides support by investigating the feasibility of developing reference materials suitable for the calibration of the haemoglobin measurements.

This is a good step forward towards the standardisation of FIT tests contribution to the health assurance of many citizens.

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