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Updated: Feb 8, 2026

Modeling Neonatal Intraventricular Hemorrhage Through Intraventricular Injection of Hemoglobin

Modeling Neonatal Intraventricular Hemorrhage Through Intraventricular Injection of Hemoglobin

Published on: August 25, 2022

血液製剤施設におけるヘモグロビン測定不確かさ推定における新たな実践

Maria Helena Sousa Timóteo¹, Ana Sofia R Tavares¹, Paulo Pereira¹

¹Lisbon School of Health, Polytechnic University of Lisbon, Portugal.

Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis

|February 6, 2026

Abstract:

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.

キーワード:

生物学的変動ドナー選別ヘモグロビン検査 ISO 15189 ISO/TS 20914 IVDR 測定不確かさ輸血の安全性

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