Authors' objectives:

The aim of this report was to evaluate the transient solution whereby molecular diagnostics were introduced into the Belgian health care system based on the funding of 18 Centres for Molecular Diagnosis, and to develop a framework for the evaluation and introduction of new molecular tests.

Authors' results and conclusions: The CMD's introduced a broad range of 94 molecular tests while the yearly overall CMD health insurance budget remained fixed at 6,5 million Euro. Over the years there was an increase in the volume of tests both for microbiology (117 139 tests in 2004) and haemato-oncology (29 611 tests in 2004). Using the new real-time polymerase chain reaction (PCR) technology the cost per test decreased to an average of 33 Euro for a PCR test performed in duplicate. The majority of the tests are performed using in-house PCR methods ("home-brew"), and most of these methods have not been validated. There was little documented activity towards tests standardisation and evaluation of the clinical or diagnostic efficacy of the tests. Non-CMD hospitals express the need for a more efficient communication and a faster test turn around time for specific tests. In contrast to the situation in Europe, molecular testing kits in the US must undergo a pre-market evaluation and GMP standards are also required for components of in-house tests. The proposed model for test evaluation was applied for a number of molecular tests: detection, quantification in genotyping of HCV-RNA (of clinical use and cost-effective); PCR enterovirus in meningitis (technical accuracy not sufficient); PCR t(14;18) in follicular lymphoma (at diagnosis, diagnostic performance of FISH is superior versus PCR); PCR Factor V Leiden (clinical impact has not been demonstrated unequivocally).

Authors' recommendations: A model for the evaluation of (novel) molecular tests is being proposed. This model consists of a 6 point scale to judge the diagnostic efficacy of a test, and a number of conditions to arrive at test effectiveness under routine conditions. These include appropriate requesting of tests, test quality (compulsory ISO accreditation and participation to external quality assessment programs for all tests is recommended), and service requirements (a maximum test turnaround time and standardised reporting). Health authorities should build the necessary expertise for the evaluation of individual tests. Where needed, the appropriately designed studies to evaluate the diagnostic efficacy level should be financed. Microbiology tests with proven clinical utility and a large volume can be reimbursed as other laboratory tests. Rare microbiology tests are best performed at one or a few reference centres for reasons of expertise and quality. Molecular tests in haemato-oncology are best performed in laboratories which also perform the cytogenetic testing, as there is a need for stepwise testing and an integrated interpretation of these complex tests.

Authors' methods: Overview

Project Status: Completed

URL for project: http://www.kce.fgov.be/index_en.aspx?SGREF=5221&CREF=9328

Year Published: 2005

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Belgium

Organisation Name: Belgian Health Care Knowledge Centre

Contact Address: Administrative Centre Botanique, Doorbuilding (10th floor), Boulevard du Jardin Botanique 55, B-1000 Brussels, Belgium tel: +32 2 287 33 88 fax: +32 2 287 33 85

Contact Name: info@kce.fgov.be

Contact Email: info@kce.fgov.be

Copyright: Belgian Health Care Knowledge Centre (KCE)