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Emerging practices in the estimation of hemoglobin measurement uncertainty in blood establishments

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Resumo:Measurement uncertainty (MU) is increasingly recognized as a critical analytical parameter within ISO and European regulatory frameworks. In transfusion laboratories, where hemoglobin testing determines donor eligibility and informs transfusion decisions, MU directly impacts patient and donor safety. This study applies ISO/TS 20914:2019 to estimate MU in hemoglobin testing using the cyanmethemoglobin method in EDTA-K3 venous blood. A parametric simulation model informed by EFLM biological variation data was used to evaluate three scenarios: (1) within-laboratory imprecision, (2) addition of calibrator uncertainty, and (3) incorporation of significant bias uncertainty. All scenarios met desirable (2.7 %) and minimum (4.1 %) performance targets for allowable uncertainty. These findings reinforce the integration of MU estimation as a European and ISO-endorsed best practice in transfusion laboratory medicine. This approach supports traceable, risk-informed decision-making, aligning transfusion services with ISO 15189:2022 requirements.
Autores principais:Timóteo, Maria Helena
Outros Autores:Tavares, Ana Sofia; Pereira, Paulo
Assunto:Biological variation Donor screening Hemoglobin testing ISO 15189 ISO/TS 20914 IVDR Measurement uncertainty Transfusion safety
Ano:2026
País:Portugal
Tipo de documento:artigo
Tipo de acesso:acesso embargado
Instituição associada:Instituto Politécnico de Lisboa
Idioma:inglês
Origem:Repositório Científico do Instituto Politécnico de Lisboa

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