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...

Critical values are those associated with imminent danger unless acted upon promptly. Critical value menus often include results that do not fit this definition, leading to highly variable practice in adult and pediatric laboratories. Existing menus may be subdivided into more uniform tiers of severity: the highly...

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 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...

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...

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...

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...