EC4 EQUAL PROJECT - Workpackages

No

Workpackage title

Description

1

Project Management

Overall Coordination of the project and management issues of every contractor

2

Planning of the activities meeting

Organisation of the Scientific Programme of a Three-day Meeting of the partners for the discussion of the methodological EQUAL programmes to be implemented on the basis of previous experiences. Each of the three EQUAL programmes will be defined in terms of procedures, reagents and samples to be analysed as well as the approach for the elaboration of the data. Additional points will be the definition of a questionnaire to be submitted to the laboratories performing molecular diagnostics, the invitation letter explaining the aim of this EU project, and the information about the existing EQA programmes for specific analytes already active and available.

3

Participant list and questionnaire

Structuring the list of the participating laboratories to the three different EQUAL schemes. Publication of the survey using the data of the questionnaire. Through EC4, FESCC, other Scientific Societies of Medical Genetics as well as using the mailing lists of the already existing EQA programmes in Molecular Diagnostics, the involved partners will contact Laboratories of the European Union Member States, of the Associated candidate States and of the other Associated Countries informing them about this initiative. Also the Presidents of the National Societies of Clinical Chemistry and of Medical Genetics will be contacted to inform them about this initiative asking them to identify laboratories potentially interested to this activity.

4

Implementation of EQUAL-qual

Implementation of EQUAL-qual suitable for laboratories performing Qualitative PCR Based Assays. Procedures, reagents, samples to be delivered related to the EQUAL-qual will be defined. These protocols will be first tested in the respective laboratories to evaluate their suitable use. Reagents and samples will be dispensed in aliquots and, after stability evaluation, stored until delivery. Additional activities include: labeling of the tubes, instruction protocols, additional educational material. An appropriate web-site for contacts, instructions and software for analysis of the results will be implemented.

5

Implementation of EQUAL-quant

Implementation of the EQUAL-quant suitable for participating Laboratories performing Quantitative PCR based Assays. Procedures, reagents, samples to be delivered related to the EQUAL-quant will be defined. These protocols will be first tested in the respective laboratories to evaluate their suitable use. Reagents and samples will be dispensed in aliquots and, after stability evaluation, stored until delivery. Additional activities include: labeling of the tubes, instruction protocols, additional educational material. An appropriate web-site for contacts, instructions and software for analysis of the results will be implemented.

6

Implementation of EQUAL-seq

Implementation of the EQUAL-seq suitable for participating laboratories performing PCR and Sequencing based Assays. Procedures, reagents and the samples to be delivered related to the EQUAL-seq will be defined. These protocols will be first tested in the respective laboratories to evaluate their suitable use. Reagents and samples will be dispensed in aliquots and, after stability evaluation, stored until delivery. Additional activities include: labeling of the tubes, instruction protocols, additional educational material. An appropriate web-site for contacts, instructions and software for analysis of the results will be implemented.

7

Activation of EQAS Programmes analysis of results

Activation of the EQUALs and delivery of the samples to the participant laboratories. Performing of the procedures. Return of the results. Analysis of the data. Participating Laboratories will receive the requested methodological EQUAL programmes. They will perform the procedures reported within the indicated time interval and return of the results by mail or through the web-site. Through a comparative evaluation of the PCR products and interpretation of the PCR results performed by both the participating laboratories or by the laboratories of the project partners it will be possible to analyse the results of the EQUAL-qual. For the EQUAL-quant and EQUAL-seq results the results performed by the participating laboratories by mail or by the corresponding reference web sites. Results of the three methodological EQA programmes will be analysed with appropriate software and made available to the participating Laboratories using eventually, mailing, e-mailing or contacts with the web site.

8

Evaluation of the activity

Meeting of the Partners and discussion of the data. Publication of the results of the three methodological EQUAL programmes. A three days meeting will be held in Florence with all the partners for the evaluation of the results of the three methodological EQUAL programmes. Each programme will be considered separately in order to evaluate the role of the instrumentation, reagents and procedures used by the participating laboratories as potential factors influencing performance and reliability of the results. This will be possible in most cases on the basis of the information requested to the participating laboratories as well as on the interpretation of the results of the single laboratory. The critical evaluation of the results of these methodological EQUAL programmes will be used for planning the content and the practical activities of the training courses reported in the WP9. The results of these three methodological EQUAL programmes will be used for publications.

9

Training courses

On the basis of the results of the methodological EQUAL programmes and of their evaluation as indicated in the WP7, several training courses will be organised in Italy, in Germany, in the Netherlands, in Czech Republic, with the active participation also of the partners Optimal number of participants would be between 10-20. Personnel actively involved in Molecular Diagnostic including those participating to the three Methodological Programmes and in particular those with low proficiency results will be invited to participate to one of these meetings. The Methodological skills required to improve analytical performance will be reviewed during the courses and then tested allowing the participants to perform for the second time the corresponding methodological EQUAL programme. Comparison of the proficiency after training will be used to judge the efficacy of the training courses. Additional lectures and educational sessions addressed to other relevant issues of the EQUAL programmes will be also included in the training courses, such as sample collection, clinical collection of the data and interpretation of the assay results. Courses will be addressed mainly to Genetic Tests or Clinical Chemistry Tests on the basis of the additional competencies available.

10

Dissemination

Dissemination of the results in National/European/International meetings by the Partners. Diffusion of educational material through the web. Reliability of the Clinical Chemistry data and in particular of the Molecular Diagnostics data is often a major topic in the national and European meetings of Clinical Chemistry or of Medical Genetics. In order to spread the information of results of this EU supported project, the partners through contacts with EC4, national scientific societies and Laboratory Medicine organisations, will be invited to present lectures on the results of this activity. Educational material will be presented and made available through the scientific publications and the web sites of the partners.

11

Exploitation prospective view

Critical evaluation of the various project steps and of the available network of participating laboratories can be used for planning future activities such as Marie Curie training courses in Quality of Molecular diagnostics. Moreover, the possibility to develop further methodological EQUAL programmes will be proposed. Other methodologies, that are close to be widely applied in Laboratory Medicine, such as for instance the DNA-chip based assays, can be further implemented.

12

Evaluation of the Project and Final Report - Meeting

A Three days meeting will be held in Florence with the Partners for an overall evaluation of the project and in particular on the role of the methodological EQUAL programmes and of the Training courses in supporting proficiency of the Molecular Diagnostics for the Clinical Chemistry or Medical Genetics Laboratories. On the basis of the obtained results and of the interest of the participating laboratories to these Methodological EQUAL programmes it will be discussed if may be useful to continue to make available these programmes eventually through specific accredited agencies already involved in other EQUAL programmes for Molecular Diagnostics