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- Title
The role of analytical performance specifications in international guidelines and standards dealing with metrological traceability in laboratory medicine.
- Authors
Greg Miller, W.
- Abstract
The goal of metrological traceability is to have equivalent results for a measurand in clinical samples (CSs) irrespective of the in-vitro diagnostic medical device (IVD-MD) used for measurements. The International Standards Organization standard 17511 defines requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples used with IVD-MDs. Each step in metrological traceability has an uncertainty associated with the value assigned to a material. The uncertainty at each step adds to the uncertainty from preceding steps such that the combined uncertainty gets larger at each step. The combined uncertainty for a CS result must fulfil an analytical performance specification (APS) for the maximum allowable uncertainty (umaxCS). The umaxCS can be partitioned among the steps in a metrological traceability calibration hierarachy to derive the APS for maximum allowable uncertainty at each step. Similarly, the criterion for maximum acceptable noncommutability bias can be derived from the umaxCS. One of the challenges in determining if umaxCS is fulfilled is determining the repeatability uncertainty (uRw) from operating an IVD-MD within a clinical laboratory. Most of the current recommendations for estimating uRw from internal quality control data do not use a sufficiently representative time interval to capture all relevant sources of variability in measurement results. Consequently, underestimation of uRw is common and may compromise assessment of how well current IVD-MDs and their supporting calibration hierarchies meet the needs of clinical care providers.
- Subjects
INTERNATIONAL Organization for Standardization; STANDARDS; CLINICAL pathology; PATHOLOGICAL laboratories; INTERNAL auditing; MEDICAL equipment; CLINICAL medicine; QUALITY control
- Publication
Clinical Chemistry & Laboratory Medicine, 2024, Vol 62, Issue 8, p1462
- ISSN
1434-6621
- Publication type
Article
- DOI
10.1515/cclm-2023-1201