Current performance of C-reactive protein determination and derivation of quality specifications for its measurement uncertainty
Articolo
Data di Pubblicazione:
2023
Citazione:
Current performance of C-reactive protein determination and derivation of quality specifications for its measurement uncertainty / F. Borrillo, M. Panteghini. - In: CLINICAL CHEMISTRY AND LABORATORY MEDICINE. - ISSN 1434-6621. - 61:9(2023), pp. 1552-1557. [10.1515/cclm-2023-0069]
Abstract:
From External Quality Assessment data, current harmonization of CRP measuring systems appears to be satisfactory, the inter-Assay CV being well below 10%. The inter-method variability is even better (close to 3%) when the widely used measuring systems are compared at CRP concentrations employed as cut-off for detecting sub-clinical infection (i.e., 10.0 mg/L) and measurement variability estimated, according to ISO 20914:2019 Technical Specification, from the intermediate within-lab reproducibility of 6-month consecutive measurement data. According to the state-of-The-Art model (which is better suited for CRP), the maximum allowable measurement uncertainty (MAU) for CRP measurement on clinical samples with 10.0 mg/L concentrations is 3.76% (desirable quality). As measurement uncertainty (MU) of the only available reference material (ERM-DA474/IFCC) is ∼3%, to fulfil desirable MAU on clinical samples, IVD manufacturers should work to keep the contribution of remaining MU sources (commercial calibrator and intermediate within-lab reproducibility) lower than 2.3%.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
analytical performance specifications; C-reactive protein; measurement uncertainty; metrological traceability;
Elenco autori:
F. Borrillo, M. Panteghini
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