A step by step guide to colorectal cancer screening test for laboratories


Every year in Europe there are a quarter of a million of new colorectal cancer cases diagnosed.  But colorectal cancer is also highly treatable if diagnosed in its early stages. This is why since 2003 the EU has been working to implement population-based evidence-based screening as recommended intervention in early detection of cancer. For colorectal cancer this is done through the search of occult blood in the faeces. Immunochemical tests (FIT) are the preferred technique for this. Only in 2015, 4 300 000 such tests have been performed in the EU.

Given the impressive number in population potentially interested by the testing and subsequent economic costs for the healthcare systems, it is essential that the implementation of such screening programmes ensure optimal quality at each step of the process. This Guide proposes a step-by-step operational guidance to laboratories based on what recommended in the 2010 European Guidelines for Quality Assurance in colorectal cancer screening and diagnosis and by the World Endoscopy Organisation "Fit for screening" Expert Working Group, but that could be applicable by all: accredited/certified and non-accredited/non-certified laboratories.

FIT can help detecting advanced polyps as well as cancers. Usual FIT protocols only need one stool sample. If the test is positive, a colonoscopy will be needed to find the reason for the bleeding. The Guide aims to provide laboratories with the necessary guidance for proper process management along the ISO15189 requirements as foreseen by the requirement 4.12 of 2010 European Guidelines; in this way this Guide provides a very practical and useful tool for colorectal cancer screening programmes aiming to adhere, via those Guidelines, to 2003 Council Recommendations on cancer screening. JRC scientist Silvia Deandrea has collaborated with the "Italian group for colorectal screening" (GISCoR) to the publication of this Guide fully available in English and Italian.

Quality assurance at each step of the screening process, from the selection of the FIT test and execution of test, must be guaranteed to citizens.  Poorly performed screening process may, in fact, cause avoidable anxiety and morbidity, inappropriate economic cost, and exposure to unnecessary risk of invasive procedures for detection and diagnosis as well as for removal of lesions detected in screening.

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Colorectal cancer is the most common newly-diagnosed cancer and the second most common cause of cancer deaths in Europe. For this reason colorectal cancer is an extremely impacting health problem across the EU and in future there could be an increase in the number of cases driven by population growth and ageing in condition of poor diet and lifestyle.

Moreover, there are persistent differences in the survival of patients across Europe suggesting that there are health inequalities that could be reduced through coordinated European action such as the European Commission Initiative on Colorectal Cancer (ECICC).

ECICC aims to provide individuals with a quality assurance scheme developed using a person-centred approach which is based on evidence, with the objective of reducing these health inequalities. The European Guidelines of 2010 will be updated, but the importance of ensuring quality of FIT tests will stay. The FIT Guide, and its possible future updates, will therefore remain an important implementation tool also for the future EU actions on colorectal cancer.

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