Abstract
Background. Colorectal cancer (CRCA) is the second most frequent malignant disease in Europe.
CRCA screening we began in the Czech Republic in 1994, and population-based national screening with FOBT was started in 2002, since 2009 with immunochemical test (FIT). External quality assessment (EQA) of haemoglobin determination in the stool has been started in January 2012 as a part of the national EQA.
The aim was to improve the analytical quality of new, quantitative FIT for colorectal cancer screening. This EQA programme is provided by SEKK (member of EQALM) which is accredited according to ISO/IEC17043:2010 and provides EQA programmes for Czech and Slovak republics.
This study will compare our new Czech FOB EQA with 15 years running ECQS annual Eiken program for users of OC-Sensors. Methods.
In the Czech Republic the Faecal Occult Blood (FOB) EQA programme is organised 2-times per year, in Japan EQCS once per year, with 2 liquid samples produced by Eiken. The results are collected using web application and evaluated according to the ISO13528.
We use robust means of all results as the assigned value for each sample. Also group based statistics (based on manufacturers of kits) are evaluated.
Results: There ran 2 rounds of the new FOB EQA programme up to now. Participants in two rounds - May (n=34) and October (n=32) - analysed samples with OC-Sensor analyser (mean CV% were 10 and 8.7), Sentinel-Gold methods (mean CV% were 16 and 18) and Smart Eurolyser POCT (mean CV% were 52 and 76).
Eiken ECQS data from 880 facilities indicating smaller CV% with OC-Sensor Diana (3.5 and 3.2), OC-Sensor Micro (5.2 and 3.7), others analyzers (5.8 and 12). Conclusions.
The new FOB EQA programme that started in January 2012 was joined by 33 clinical laboratories analysing quantitative FIT samples