Therapeutic drug monitoring of monoclonal antibodies in chronic inflammatory diseases: A snapshot of laboratories and applications across Europe.

The European Cooperation in Science and Technology (COST) action ENOTTA (The European Network on Optimising Treatment with Therapeutic Antibodies in chronic inflammatory diseases) was launched in 2022. To pave the way for harmonization of analytical methods for quantitation of serum levels of therapeutic antibodies in research and clinical settings, ENOTTA recently performed an online survey mapping laboratories in the field. The survey, which contained 30 questions surrounding therapeutic drug monitoring of relevant drugs and anti-drug antibodies, was distributed via the ENOTTA and European Federation of Clinical Chemistry and Laboratory networks.

Systematic review and meta-analysis of within-subject and between-subject biological variation data of coagulation and fibrinolytic measurands.

Objectives: The diagnosis and monitoring of bleeding and thrombotic disorders depend on correct haemostatic measurements. The availability of high-quality biological variation (BV) data is important in this context. Many studies have reported BV data for these measurands, but results are varied.

The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: code of conduct, version 3 - 2023.

Whilst version 2 focussed on the professional conduct expected of a Specialist in Laboratory Medicine, version 3 builds on the responsibilities for ethical conduct from point of planning to point of care. Particular responsibilities that are outlined include: - The need for evidence when planning a new service, providing assurance that a new test does not do harm - Maintaining respect for patient confidentiality, their religious/ethnic beliefs, the need for informed consent to test, agreement on retrospective use of samples as part of governance envelopes in the pre-analytical phase - Ensuring respect for patient autonomy in the response to untoward results generated in the analytical phase - Supporting the safety of patients in the post-analytical phase through knowledge-based interpretation and presentation of results - The duty of candour to disclose and respond to error across the total testing process - Leading initiatives to harmonise and standardise pre-analytical, analytical and post-analytical phases to ensure more consistent clinical decision making with utilisation of demand management to ensure more equitable access to scarce resources - Working with emerging healthcare providers beyond the laboratory to ensure consistent application of high standards of clinical care In identifying opportunities for wider contributions to resolving ethical challenges across healthcare the need is also highlighted for more external quality assurance schemes and ethics-based quality indicators that span the total testing process.

From big data to better patient outcomes.

Among medical specialties, laboratory medicine is the largest producer of structured data and must play a crucial role for the efficient and safe implementation of big data and artificial intelligence in healthcare. The area of personalized therapies and precision medicine has now arrived, with huge data sets not only used for experimental and research approaches, but also in the "". Analysis of real world data requires development of legal, procedural and technical infrastructure.

The Academy of the European Federation of Clinical Chemistry and Laboratory Medicine and the European Register of Specialists in Laboratory Medicine: guide to the Academy and the Register, version 4 - 2020.

The 4th version of the guide to the Register for European Specialists in Laboratory Medicine (EuSpLM) established by the European Communities Confederation of Clinical Chemistry and Laboratory Medicine describes the transfer of the register to the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) in 2016, the extension in 2018 of the Register beyond the European Union to Europe and the benefits of membership of the EFLM Academy to which the Register transferred on the Academy's launch in 2019. The Academy offers EuSpLM registrants access to benefits that include reduced registration rates at selected conferences and free subscription to . With effect from 2020 eligibility was extended to anyone with an interest in laboratory medicine.

Non-HDL Cholesterol or apoB: Which to Prefer as a Target for the Prevention of Atherosclerotic Cardiovascular Disease?

Purpose Of Review: Guidelines propose using non-HDL cholesterol or apolipoprotein (apo) B as a secondary treatment target to reduce residual cardiovascular risk of LDL-targeted therapies. This review summarizes the strengths, weaknesses, opportunities, and threats (SWOT) of using apoB compared with non-HDL cholesterol.

Recent Findings: Non-HDL cholesterol, calculated as total-HDL cholesterol, includes the assessment of remnant lipoprotein cholesterol, an additional risk factor independent of LDL cholesterol.

Standardizing in vitro diagnostics tasks in clinical trials: a call for action.

Translational research is defined as the process of applying ideas, insights and discoveries generated through basic scientific inquiry to treatment or prevention of human diseases. Although precise information is lacking, several lines of evidence attest that up to 95% early-phase studies may not translate into tangible outcomes for improving clinical management. Major theoretical hurdles exist in the translational process, but is it also undeniable that many studies may have failed for practical reasons, such as the use of inappropriate diagnostic testing for evaluating efficacy, effectiveness or safety of a given medical intervention, or poor quality in laboratory testing.

Clinical impact of direct HDLc and LDLc method bias in hypertriglyceridemia. A simulation study of the EAS-EFLM Collaborative Project Group.

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 (∼ 1 mmol/l) and hypertriglyceridemic (∼ 7 mmol/l) serum pools with lipid target values assigned by the Lipid Reference Laboratory in Rotterdam.

Standardization of collection requirements for fasting samples: for the Working Group on Preanalytical Phase (WG-PA) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

Standardized protocols for patient preparation for laboratory testing are currently lacking. Moreover, a great heterogeneity exists in the definitions of "fasting" currently being used among healthcare workers and in the literature. Marked metabolic and hormonal changes occur after food ingestion, mainly due to the absorption of fluids, lipids, proteins, carbohydrates and other food constituents.