In about 30-40 % of ischemic strokes, even after an extensive clinical investigation, it is not possible to determine any one etiology. It is possible that a fraction of these strokes, named cryptogenic, happen after an episode of paroxystic atrial fibrillation (AF) that was not registered. Strokes due to atrial...

When a new D-dimer method is to be implemented either as a substitute for a currently used D-dimer assay or as a supplement, maybe as a point-of-care assay, it is necessary to do a clinical comparison of the "old" assay versus the "new" assay. The major pitfalls in D-dimer comparisons are addressed in this paper.   ...

Analytical methods are often developed at one site and transferred to other sites for routine use. Increasingly, the method development is made by manufacturers of instruments and reagents. Regulatory agencies have ruled that the responsibility for the performance of IVDs in the laboratories mainly should lie with...

Sepsis and septic shock lead to local and systemic activation of different response systems, including coagulation and fibrinolysis.  Despite numerous attempts the high mortality rate of these patients has remained stable over the last 20 years. In this overview the pathophysiological insights and possible...

Sensitivity and specificity define the discriminative power of a diagnostic procedure, whereas predictive values relate to the predictive ability of a test to identify disease or its absence in individuals.  Predictive values are greatly influenced by the prevalence of the disease and should not be generalized beyond ...

The discriminative ability of a diagnostic procedure is called diagnostic accuracy, and a number of quantitative measures out of which sensitivity and specificity are mostly used in the biomedical literature can express it. Each diagnostic-accuracy measure relates to some specific aspects of a diagnostic procedure....

The field of point-of-care testing (POCT) is entering a period of rapid expansion. This expansion is being driven by new evidence for clinical effectiveness of POCT, and new technologies that allow consolidation of testing onto smaller platforms. Technological improvements will also lead to increased accuracy for...

Patients with heart failure (HF) experience significant morbidity and mortality and those admitted for acute decompensated HF are at particularly high risk for adverse events. Hospitalization represents the major component of the high cost associated with the management of patients with HF. Accordingly, early and...

Timely and accurate diagnosis of sepsis is of great importance for the choice of treatment, level of monitoring and prognosis. For this biomarkers could be a significant aid, and thus the search for and application of sepsis biomarkers are of great importance.  Current evidence suggests that C-reactive protein and...

As point-of-care applications of lab testing demand more rapid and clinically integrated order entry and results-reporting processes, it becomes paramount for the laboratory to investigate entire clinical processes. Direct observation and process mapping of these clinical applications – end to end - are "lean" tools...