Description of the EQUAL Project

The main objective of the EQUAL project is the implementation of three methodological EQUAL programmes for molecular diagnostics and the evaluation of their role in terms of improving the quality of Molecular Diagnostics when performed in conjunction with the existing Disease-specific EQA programmes or in absence of them.

To reach this goal the project has been developed in four main steps.

  1. The first step is to build an European network of partners expert in EQA programmes in Molecular Diagnostics. The result of this collaboration is the proposal of a panel of EQA programmes in Clinical Molecular Diagnostics addressed to the evaluation of the Performance and Interpretation of PCR based assay methods (go to DETAILED DESCRIPTION OF THE EQUAL PROGRAMMES). Three EQA programmes are proposed: one for Qualitative PCR based assays (see EQUAL-qual), the second one for Quantitative PCR assays (5’nuclease based assays) (see EQUAL-quant) and for Sequencing based assays (see EQUAL-seq). Web sites with all the information and analysis of the data will be implemented (see LINKS).
  2. The second step is to individuate a number of participating laboratories where the proposed EQUAL programmes will be tested. Through Scientific organisations and Societies of Laboratory Medicine (such as EC4, FESCC etc) and contacts with Companies producing reagents and instruments for Molecular Diagnostics, these Methodological EQUAL programmes will then be made available to the laboratories performing Molecular Diagnostics on a voluntary basis (go to the Application Form) with the aim to assess the performances of the technical procedures common to these methods. Specifically developed questionnaires and appropriate procedures of data analysis will be implemented in order to monitor the efficacy and the appreciation of these methodological EQA programmes. It is expected that several hundreds of Diagnostic Laboratories will participate at this survey. A high number of participating laboratories is very important for a significant statistical evaluation of any EQAS programme; in this sense this Multi-national EQA programme survey requires an European approach as an appropriate number of participating laboratories is not easily reachable at the level of a single country.
  3. The third step of the EQUAL Project is the organisation of several Training Courses (see Training Courses Infos) where all the laboratory facilities and competences are available. Personnel involved as participants to the three Methodological Programmes in general but those with low proficiency results in particular will be invited to participate to one of these Courses. The Methodological skills required to improve analytical performance will be reviewed during the courses on the basis of the results of the survey. After then participants will 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 EQA programmes will be also included in the training courses, such as sample collection, clinical collection of the data and interpretation of the assay results. Some of the courses will be addressed mainly to Genetic Tests, others to Clinical Chemistry Tests.
  4. The last step is a critical revision of the results collected during the Project i.e.: the results of the performance of the three Methodological EQUAL programmes, the results and the appreciation degree of the Training Courses, their impact on proficiency of the Disease-specific EQA programmes. It is expected that the availability of EQA programmes addressed to methodological aspects with those for specific analytes, together with an active European network and appropriate international training activities will demonstrate that they can contribute to improve the overall quality of molecular diagnostics at the European level.