D-dimer is a soluble fibrin degradation product deriving from the plasmin-mediated
degradation of cross-linked fibrin. D-dimer can hence be considered a biomarker of …

Hemolysis is conventionally defined as membrane disruption of red blood cells and other
blood cells that is accompanied by subsequent release of intracellular components into the …

Sažetak Calculating the sample size in scientific studies is one of the critical issues as
regards the scientific contribution of the study. The sample size critically affects the …

Verification of hematology analyzers (automated blood cell counters) is mandatory before
new hematology analyzers may be used in routine clinical care. The verification process …

The definition and enforcement of reference measurement systems, based on the
implementation of metrological traceability of patient results to higher-order (reference) …

IVD manufacturers have total responsibility in terms of the traceability of marketed in vitro
diagnostic medical devices (IVD-MD). This includes the provision of a quality control (QC) …

To be accurate and equivalent, laboratory results should be traceable to higher-order
references. Furthermore, their quality should fulfill acceptable measurement uncertainty …

In recent decades, the study of biological variation of laboratory analytes has received
increased attention. The reasons for this interest are related to the potential practical …

Method evaluation is one of the critical components of the quality system that ensures the
ongoing quality of a clinical laboratory. As part of implementing new methods or reviewing …

BACKGROUND Since 2010, a certified reference material ERM-DA471/IFCC has been
available for cystatin C (CysC). This study aimed to assess the sources of uncertainty in …