Senslab - an EKF Diagnostics Company - GmbH Leipzig, Sachsen, Germany
Background/Case Studies: Accurate hemoglobin (Hb) determination is essential in clinical diagnostics and pre-donation screening to prevent anemia-related complications and ensure blood quality. The use of point-of-care testing (POCT) devices for Hb determination marks a technological advancement for blood banks, offering improved testing methods, portability, and ease of use that enhance donor safety and blood component quality. This study evaluates the performance of the DiaSpect Tm hemoglobin analyzer in comparison with HemoCue 301, Hemo Control, and the ABL90 Flex blood gas analyzer using venous blood as a standardized specimen.
Study
Design/Methods: Venous blood samples (n = 94, measured in duplicate, N = 188) from 7 healthy adult donors were collected and stabilized with EDTA. To achieve a range of hematocrit (Hct) values, samples were prepared by mixing venous whole blood with plasma. Hematocrit was determined via microhematocrit centrifugation. Hb levels were measured using DiaSpect Tm, HemoCue 301, Hemo Control (HC), and ABL90 Flex under controlled lab conditions (20–25 °C). Bland-Altman plots and linear regression analyses assessed bias, agreement, and correlation.
Results/Findings: Hb concentration ranged from 3.5 to 26.9 g/dL (ABL90 Flex). Compared to HemoCue 301, DiaSpect Tm and Hemo Control showed a positive mean bias of +0.557 g/dL and +0.474 g/dL, respectively. Against ABL90 Flex, DiaSpect Tm showed a negative mean bias of –0.3403 g/dL. Bland-Altman analysis revealed acceptable agreement; Pearson correlation coefficients exceeded 0.998 for all device pairings with regression slopes near 1.0. Conclusions: DiaSpect Tm and Hemo Control showed slightly higher Hb readings compared to HemoCue 301 and demonstrated strong correlation with both HemoCue and ABL90 Flex. These findings support the use of DiaSpect Tm as a reliable POCT device for pre-donation screening when standardized against reference analyzers.