Current performance of C-reactive protein determination and derivation of quality specifications for its measurement uncertainty
| Autor: | Francesca Borrillo, Mauro Panteghini |
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| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | Clinical Chemistry and Laboratory Medicine (CCLM). |
| ISSN: | 1437-4331 1434-6621 |
| DOI: | 10.1515/cclm-2023-0069 |
| Popis: | 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%. |
| Databáze: | OpenAIRE |
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