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%.

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]

Current performance of C-reactive protein determination and derivation of quality specifications for its measurement uncertainty

M. Panteghini
Ultimo
2023

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%.
analytical performance specifications; C-reactive protein; measurement uncertainty; metrological traceability;
Settore BIO/12 - Biochimica Clinica e Biologia Molecolare Clinica
2023
13-feb-2023
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/986868
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