CLSI X5-R — Metrological Traceability
21/10/2006 20:05
X5-R was recently published to help resolve confusion surrounding the best practical approach to metrological traceability, ensuring comparable results regardless of location or device.
X5-R — Metrological Traceability and Its Implementation; A Report
X5-R was recently published to help resolve confusion surrounding the best practical approach to metrological traceability, ensuring comparable results regardless of location or device.
Metrological traceability is facilitated by expressing results in common units, producing a measurement system that supports shared reference intervals and decision limits. Results from a harmonized measurement system support the establishment of common reference intervals and decision limits, whic allows for global application of clinical study findings. However, much confusion exists about how to implement the traceability scheme on a practical level. X5-R can help by:
* providing guidance for establishing traceability of the chemical calibration step in clinical laboratory measurements, based on the requirements for in vitro diagnostic (IVD) medical devices in ISO 17511 and ISO 15183, as well as the requirements for traceability in the IVD Directive;
* explaining the basics of traceability; and
* defining a reference measurement system that includes reference materials, measurement procedures, reference laboratories, and laboratory networks.