The European Society of Pathology
(ESP) established a European EQA program for testing KRAS mutations in colorectal cancer (1). This program aims to ensure optimal accuracy and proficiency in KRAS mutation testing across all countries or institutions in the World.
A first European pilot KRAS 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. The practical organization of this European QA program is done in collaboration with a European working group lead by Prof dr H Van Krieken, executive board member of the ESP and the Research unit Biomedical Quality Assurance of the University of Leuven lead by Prof dr E Dequeker. The scheme organisers are member of this European working group and will be in close contact with the European QA program coordinator. The aim of the KRAS EQA scheme is to evaluate the reliability of the analysis of the KRAS test including correct identification of the presence and type of mutations and the writing of a report.
Each laboratory performing KRAS testing can participate to the EQA scheme.
Participants of Regional EQA scheme 2009
Countries that were included in Regional scheme 2010
Participants of European EQA scheme 2010
All countries can participate in upcoming European EQA schemes
Laboratories interested to participate in the KRAS EQA scheme need to register as a new participant to have a username and password. In case your laboratory does not have a username and password, please fill in this form. With this username and password the laboratory can log in to the EQA participant's area. In the participants area the laboratory can access the registration form for the current EQA scheme, can submit reports and consult results of previous years (if submitted online).
Each year, all laboratories that have an account will receive an invitation via email to register for the KRAS EQA scheme on-line. An identification number is assigned to each participant automatically upon registration.
A fee for reimbursement of 550€ will be asked to the participants for the organization cost, preparation and sending of the samples and assessment of the results.
In the KRAS EQA scheme, the tasks of preparing and sending the samples can be assigned to laboratories of the scheme organizers. Scheme organizers are in close contact with the European EQA coordinator. We assure that these tasks are performed by competent laboratories. The ESP KRAS EQA coordination center is final responsible for the EQA scheme. The samples contain the same type of mutations, which will be distributed to all laboratories. Given the kind of starting material it is impossible to send all the participants slides coming from the same patients.
The box sent to the participant contains sections of paraffin-embedded material from 10 different invasive colorectal carcinoma harboring a possible KRAS mutation. You 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 on behalf of KRAS testing. The laboratory needs to determine the percentage of tumour cells and test these samples for the presence of KRAS mutations, using the 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.
Participants are divided in subschemes. Each subscheme has a scheme organizer who sets up the KRAS EQA scheme in this subscheme. The scheme organizers prepare the samples and distribute them to the participants. Coordination and evaluation of the results is done by the KRAS EQA scheme coordination center in Leuven together with the medical/technical expert.
The participants should provide feedback on the mutations tested for, the methods used, the % of tumor, the obtained genotype results together with the raw data and written reports. All the results are evaluated under the coordination of the coordination center in Leuven.
Report:
The laboratory should submit a report for the first 3 samples. A report represents the report a laboratory normally issues to the medical doctor who requested the KRAS test. Therefore genotype and interpretation information should be present in the reports submitted to the KRAS 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 the submitted results and raw data. Results of the EQA schemes will be announced after discussion in the European working group. These results will be made available anonymously among the participants but each participating laboratory will receive individual feedback.
Participants with a genotyping score ≥90% will be listed on the website. All participants receive a certificate for participation.
The fact of participation, raw data and the individual report are confidential between the individual laboratory and the scheme organizer as well as the European QA coordinator (and in exceptional circumstances the chair of the European working group).
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