The European Society of Pathology
(ESP) established a European EQA program for testing biomarker mutations in colorectal cancer (1). This program aims to ensure optimal accuracy and proficiency in biomarker testing in colorectal cancer across all countries.
A first European pilot EQA scheme was running May – June 2009. Based on these experiences Regional and European EQA schemes were organized in different countries in 2009 and 2010.
Since then, the ESP Colon EQA scheme has been organized on a yearly basis.
Each laboratory performing biomarker testing in colorectal cancer can participate. Laboratories performing adequate in the EQA round will be published on the ESP website.
The ESP EQA is one of the founding members of the International Quality Network for Pathology (IQN Path,www.iqnpath.org). The mission of IQN Path is to improve clinical implementation of tissue-based biomarkers through multi-stakeholder cooperation. This central association will enable an exchange of expertise between key opinion leaders, will facilitate the
development of multidisciplinary guidelines, develop workshops and training, and will promote EQA.
From 2017, the organisation of the ESP EQA programmes was done together with the new ESP-QA foundation.
In 2013, the EMA stated that wild-type RAS status (KRAS exon 2, 3, 4 and NRAS exon 2, 3, 4) is required before initiating treatment with panitumumab or cetuximab. Since then, samples harbouring KRAS, NRAS and BRAF mutations are included in the scheme.
The EQA scheme is designed to evaluate the reliability of RAS and BRAF testing, including correct identification of the presence and type of mutations and the writing of a clinical report. Full RAS testing is required; BRAF testing is optional. No genotyping errors are tolerated for successful participation.
The EQA samples need to be tested according to the laboratory's routine practices. Participating in an EQA program gives the laboratory an opportunity to verify and improve their diagnostic practices.
The EQA program is coordinated by the Biomedical Quality Assurance Research Unit of the University of Leuven, led by prof. dr. E Dequeker works. There is close collaboration with the medical expert prof. dr. H Van Krieken and technical expert prof. dr. Marjolijn Ligtenberg, both from the RadboudUmc in Nijmegen.
The ESP EQA schemes are accredited by BELAC conform the ISO 17043, (PT-215), which is the international standard for conformity assessment of proficiency testing.
For 2020, no Colon EQA scheme is organized by the Biomedical Quality Assurance Research Unit of the University of Leuven.
Laboratories interested in other ESP EQA schemes (e.g. for NSCLC) can create an account to obtain a username and password. They can do so by filling in this form.
Coordination
In the ESP Colon EQA scheme, the tasks of validating and preparing the samples are assigned to our reference laboratory, which works in close contact with the European EQA coordinator. We assure that these tasks are performed by a competent laboratory. The ESP EQA coordination center has final responsibility for the EQA scheme.
Harmonization in material and genotypes between the different participants is aimed for as much as possible. Given the kind of starting material it is impossible to send all the participants slides coming from the same patients. The samples are shipped to the laboratories by the EQA Coordination Centre.
Samples
The box sent to the participant contains sections of paraffin-embedded material from 10 different invasive colorectal carcinoma harboring possible mutations. The laboratory will receive 3 sections per sample, thus 30 in total. The first section of each sample is a 6 µm-section for HE-staining, the second and third sections are 6 µm-sections for DNA-isolation for mutation testing. The laboratory needs to determine the neoplastic cell content and test these samples for the presence of mutations, using their routine protocols. Slides are clearly labeled with a specimen ID and section number.
The materials distributed are provided as specimens for the sole purpose of enabling external quality assessment at the recipient's laboratory during the current distribution and must not be tested for any other target than that which is requested by the EQA scheme. They do not constitute in vitro medical diagnostic devices (IVDs), and no claim is made that they may be suitable for any other purpose or at any other point in time.
The participants should provide feedback on the mutations tested for, the methods used, the neoplastic cell content and the obtained genotype results. Written reports and a scan of HE stained slides indicating the area for determining neoplastic cell content, can be uploaded. Uploading of raw data is optional.
The laboratory should submit a written report for the first 3 samples. A report represents the report a laboratory normally issues to the medical doctor who requested the test. Therefore genotype and interpretation information should be present in the reports submitted to the ESP EQA coordination center. Reporting is allowed in the national language, but preferred in English. Reports are preferable submitted as .doc, .docx or .pdf files.
The coordination center in Leuven will coordinate the evaluation of the submitted results. Results of the EQA schemes will be announced after discussion with the assessors and the medical/technical experts. These results will be made available anonymously among the participants but each participating laboratory will receive individual feedback.
The ESP Colon EQA Scheme allows participants to react on the score and/or comments they received. All appeals should be sent via e-mail to before the appealing deadline that is indicated in the general report. The appeals will be collected and will be discussed by the assessors. The laboratories will receive an individual answer and after this, the marks become final.
For successful participation, no genotyping errors will be allowed. Laboratories that participated successfully, will be listed on the website. All participants receive a certificate of participation.
The fact of participation, the raw data and the individual report are confidential information between the individual laboratory and the scheme organizer as well as the European QA coordinator (and in exceptional circumstances the president of the ESP). All persons involved sign a confidentiality agreement.
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