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

2026-04Artigo científico Acesso embargado
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datacite.subject.sdg03:Saúde de Qualidade
dc.contributor.authorTimóteo, Maria Helena
dc.contributor.authorTavares, Ana Sofia
dc.contributor.authorPereira, Paulo
dc.date.accessioned2026-03-11T12:31:14Z
dc.date.available2026-03-11T12:31:14Z
dc.date.issued2026-04
dc.description.abstractMeasurement 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.eng
dc.identifier.citationTimóteo MH, Tavares AS, Pereira P. Emerging practices in the estimation of hemoglobin measurement uncertainty in blood establishments. Transfus Apher Sci. 2026;65(2):104401.
dc.identifier.doi10.1016/j.transci.2026.104401
dc.identifier.issn1473-0502
dc.identifier.urihttp://hdl.handle.net/10400.21/22715
dc.language.isoeng
dc.peerreviewedyes
dc.publisherElsevier BV
dc.relation.hasversionhttps://www.sciencedirect.com/science/article/pii/S1473050226000339
dc.relation.ispartofTransfusion and Apheresis Science
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectBiological variation
dc.subjectDonor screening
dc.subjectHemoglobin testing
dc.subjectISO 15189
dc.subjectISO/TS 20914
dc.subjectIVDR
dc.subjectMeasurement uncertainty
dc.subjectTransfusion safety
dc.titleEmerging practices in the estimation of hemoglobin measurement uncertainty in blood establishmentseng
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue2
oaire.citation.startPage104401
oaire.citation.titleTransfusion and Apheresis Science
oaire.citation.volume65
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameTavares
person.givenNameAna Sofia
person.identifier.ciencia-id9D10-BB39-04DF
person.identifier.orcid0000-0002-5335-7498
relation.isAuthorOfPublication13fb72b8-212a-4a99-84c3-9038d984d945
relation.isAuthorOfPublication.latestForDiscovery13fb72b8-212a-4a99-84c3-9038d984d945

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