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Langlois M.R.,European Federation of Clinical Chemistry and Laboratory Medicine EFLM | Langlois M.R.,Ghent University | van der Laarse A.,Leiden University | Weykamp C.,Queen Beatrix Hospital | And 11 more authors.
Atherosclerosis | Year: 2014

Background: Despite international standardization programs for LDLc and HDLc measurements, results vary significantly with methods from different manufacturers. We aimed to simulate the impact of analytical error and hypertriglyceridemia on HDLc- and LDLc-based cardiovascular risk classification. Methods: From the Dutch National EQA-2012 external quality assessment of 200 clinical laboratories, we examined data from normotriglyceridemic (~1mmol/l) and hypertriglyceridemic (~7mmol/l) serum pools with lipid target values assigned by the Lipid Reference Laboratory in Rotterdam. HDLc and LDLc were measured using direct methods of Abbott, Beckman, Siemens, Roche, Olympus, or Ortho Clinical Diagnostics. We simulated risk reclassification using HDL- and sex-specific SCORE multipliers considering two fictitious moderate-risk patients with initial SCORE 4% (man) and 3% (woman). Classification into high-risk treatment groups (LDLc >2.50mmol/l) was compared between calculated LDLc and direct LDLc methods. Results: Overall HDLc measurements in hypertriglyceridemic serum showed negative mean bias of-15%. HDL-multipliers falsely reclassified 70% of women and 43% of men to a high-risk (SCORE >5%) in hypertriglyceridemic serum (P<0.0001 vs. normotriglyceridemic serum) with method-dependent risk reclassifications. Direct LDLc in hypertriglyceridemic serum showed positive mean bias with Abbott (+16%) and Beckman (+14%) and negative mean bias with Roche (-7%). In hypertriglyceridemic serum, 57% of direct LDLc measurements were above high-risk treatment goal (2.50mmol/l) vs. 29% of direct LDLc (33% of calculated LDLc) in normotriglyceridemic sera. Conclusion: LDLc and HDLc measurements are unreliable in severe hypertriglyceridemia, and should be applied with caution in SCORE risk classification and therapeutic strategies. © 2014 Elsevier Ireland Ltd.

Oosterhuis W.P.,Atrium Medical | Oosterhuis W.P.,Section of Laboratory Medicine | Zerah S.,European Federation of Clinical Chemistry and Laboratory Medicine EFLM
Clinical Chemistry and Laboratory Medicine | Year: 2015

The profession of laboratory medicine differs between countries within the European Union (EU) in many respects. The objective of professional organizations of the promotion of mutual recognition of specialists within the EU is closely related to the free movement of people. This policy translates to equivalence of standards and harmonization of the training curriculum. The aim of the present study is the description of the organization and practice of laboratory medicine within the countries that constitute the EU. A questionnaire covering many aspects of the profession was sent to delegates of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and Union Européenne de Médecins Spécialistes (UEMS) of the 28 EU countries. Results were sent to the delegates for confirmation. Many differences between countries were identified: predominantly medical or scientific professionals; a broad or limited professional field of interest; inclusion of patient treatment; formal or absent recognition; a regulated or absent formal training program; general or minor application of a quality system based on ISO Norms. The harmonization of the postgraduate training of both clinical chemists and of laboratory physicians has been a goal for many years. Differences in the organization of the laboratory professions still exist in the respective countries which all have a long historical development with their own rationality. It is an important challenge to harmonize our profession, and difficult choices will need to be made. Recent developments with respect to the directive on Recognition of Professional Qualifications call for new initiatives to harmonize laboratory medicine both across national borders, and across the borders of scientific and medical professions. © De Gruyter 2015.

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