Publications by authors named "Leo H J Jacobs"

Objectives: Extensive consumption of alcohol during pregnancy can lead to severe complications for the unborn child. Carbohydrate-deficient transferrin (CDT) levels in serum have become a common biomarker for excessive alcohol intake. However, during pregnancy CDT levels can rise to levels above commonly used cut-off values, for reasons unrelated to alcohol intake.

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Background: Risk stratification of patients presenting to the emergency department (ED) is important for appropriate triage. Diagnostic laboratory tests are an essential part of the workup and risk stratification of these patients. Using machine learning, the prognostic power and clinical value of these tests can be amplified greatly.

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Article Synopsis
  • The EU Diagnostic Device Regulation (IVDR) emphasizes risk-based validation, traceability, and post-market monitoring of diagnostic devices while excluding medical services based on these devices.
  • Laboratory-developed tests (LDTs) can be used when commercial devices are unavailable, subjecting them to specific performance and safety guidelines under an ISO 15189-equivalent quality system.
  • The IVDR may lead to the disappearance of some commercial tests, necessitating urgent LDT replacements, while raising concerns about the potential loss of niche medical applications and increased costs within healthcare systems.
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Background: In 2017 the Atellica UAS 800 urine sediment analyzer was introduced by Siemens Healthineers. We investigated its applicability in the standardization and automation of the laboratory urinalysis workflow, including the prediction of urine culture outcome and glomerular pathology.

Methods: We evaluated the performance characteristics of the Atellica UAS 800 and its correlation with the iQ200 (Beckman Coulter).

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The in vitro diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of in vitro diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs).

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Objectives: Carbohydrate-deficient transferrin (CDT) measurements are commonly used for the identification and follow-up of individuals suspected of chronic alcohol abuse. This study describes the analytical characteristics of the CDT assay on the Helena Biosciences V8 electrophoresis analyzer and compares its diagnostic performance to the International Federation of Clinical Chemistry and Laboratory Medicine approved high performance liquid chromatography (HPLC) method and the N-Latex CDT immunonephelometric assay.

Methods: The analytical performance of the V8 assay, including the linearity and the imprecision, was studied at two separate locations.

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Background The morphological assessment of urinary erythrocytes (uRBC) is a convenient screening tool for the differentiation of nephrological (dysmorphic) and urological (isomorphic) causes of hematuria. Considering the morphological heterogeneity, this analysis is often perceived as difficult. There is no clear (inter)national consensus and there is a lack of external quality assessment programs.

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Background: The rapid exclusion of acute myocardial infarction in patients with chest pain can reduce the length of hospital admission, prevent unnecessary diagnostic work-up and reduce the burden on our health-care systems. The combined use of biomarkers that are associated with different pathophysiological aspects of acute myocardial infarction could improve the early diagnostic assessment of patients presenting with chest pain.

Methods: We measured cardiac troponin I, copeptin and heart-type fatty acid-binding protein concentrations in 584 patients who presented to the emergency department with acute chest pain.

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Aim: Cardiac troponin I (cTnI) and T (cTnT) are the most important biomarkers in the diagnosis of acute myocardial infarction (AMI). Nevertheless, they can be elevated in the absence of AMI. It is unclear if such elevations represent irreversible cardiomyocyte-damage or leakage from viable cardiomyocytes.

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Cardiac troponins (cTn) are the preferred markers for the diagnosis of acute myocardial infarction (AMI). The guidelines recommend the use of the 99th percentile upper reference concentration of a healthy population as the diagnostic cut-off for AMI. However, a broad range of upper reference limits is still employed, complicating the diagnosis of AMI.

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Background: Endurance exercise is frequently associated with cardiac troponin (cTn) concentrations, otherwise corresponding to minor myocardial infarction. However, research on the underlying mechanisms has been limited because of assay restraints in the low concentration range.

Methods And Results: Using the pre-commercial, highly sensitive hs-cTnT assay, cTnT concentrations were measured in samples from recreational runners obtained before and after running 5 km (trained, n = 43/untrained, n = 122), 15 km (n = 38), 21 km (n = 10), and 42 km (n = 85) (all trained).

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