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...

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 ...

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...

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...

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....

Recent studies of D-dimer as a “rule-out” test for deep venous thrombosis (DVT) frequently have used duplex ultrasound rather than venography as the gold standard. Because duplex ultrasound has limited ability to image the calf veins, there is potential for ultrasound studies to classify patients with calf DVT as...

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...

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...

Applications of point-of-care testing (POCT) for diagnostic biomarker measurement in healthcare have increased significantly in recent years in a wide range of clinical scenarios. These include infectious disease, critical care, cardiology and other areas of emergency medicine. Traditionally, routine clinical...

In an exclusive acutecaretesting.org interview, Dr Mario Plebani, Head of the Department of Laboratory Medicine at the University Hospital of Padova, Italy and international patient safety advocate, talks about how laboratory, clinicians and manufacturers can work together to reduce errors in testing and diagnosing...