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) …

Objectives Definition and fullfillment of analytical performance specifications (APS) for
measurement uncertainty (MU) allow to make laboratory determinations clinically usable …

When increasing the quality in clinical laboratories by decreasing measurement uncertainty,
reliable methods are needed not only to quantify the performance of measuring systems, but …

To be accurate and equivalent among assays, laboratory results should be traceable to
higher-order references and their quality should fulfill maximum allowable measurement …

Analytical performance specifications (APS) represent the criteria that specify the quality
required for laboratory test information to satisfy clinical needs. In 2014 the European …

In addition to the correct implementation of calibration traceability, the definition and
fulfillment of maximum allowable measurement uncertainty (MAU) are essential in assuring …

Background The JCTLM created a Task Force on Reference Measurement System
Implementation (TF-RMSI) to provide guidance on metrological traceability implementation …

Abstract Background The biological (CV I), preanalytical (CV PRE), and analytical variation
(CV A) are inherent to clinical laboratory testing and consequently, interpretation of clinical …

Measurements on clinical chemistry analysers must be verified to demonstrate applicability
to their intended clinical use. We verified the performance of measurements on the Siemens …