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Horiba Micros ES 60 Blood Cell Analyzer in Blood Donor Eligibility: A Validation Study

Background: Eligibility criteria for blood donation require hemoglobin levels of ≥12.5 g/dL for women and ≥13.5 g/dL for men, and a platelet count of ≥180 × 109/L. Screening methods before donation should ensure high accuracy, precision, and ease in operation. We assessed the performance, precision,...

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Autores principales: Tillati, Silvia, Pati, Ilaria, Delle Donne, Michela, Meneghel, Alessandra, Londero, Donatella, De Angelis, Vincenzo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9689173/
https://www.ncbi.nlm.nih.gov/pubmed/36359430
http://dx.doi.org/10.3390/diagnostics12112586
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author Tillati, Silvia
Pati, Ilaria
Delle Donne, Michela
Meneghel, Alessandra
Londero, Donatella
De Angelis, Vincenzo
author_facet Tillati, Silvia
Pati, Ilaria
Delle Donne, Michela
Meneghel, Alessandra
Londero, Donatella
De Angelis, Vincenzo
author_sort Tillati, Silvia
collection PubMed
description Background: Eligibility criteria for blood donation require hemoglobin levels of ≥12.5 g/dL for women and ≥13.5 g/dL for men, and a platelet count of ≥180 × 109/L. Screening methods before donation should ensure high accuracy, precision, and ease in operation. We assessed the performance, precision, and repeatability of the Horiba Micros ES 60 (Horiba) compared to the Beckman Coulter DXH 800. Methods: Performance was compared by testing samples for each of the 11 devices across 6 sites in the Transfusion Service of Friuli Venezia Giulia Region, Italy. We measured precision by calculating the coefficient of variation (CV), concordance with ρ-Pearson’s correlation coefficient, and accuracy with F-tests. The intra-assay agreement was examined in the 11 devices, and repeatability was performed by using CV and the Kruskal–Wallis test. Results: The precision of Horiba was acceptable. Overall, ρ-Pearson’s coefficients indicated a strong correlation and positive relationship between all variables. The Bland–Altman plots showed that most of the differences lay within the limits of agreement. All CV were below the reference threshold for all the parameters. Finally, the Kruskal–Wallis test reported non-significant statistical differences for all parameters, except platelet count (p < 0.000). Conclusions: Horiba is adequate for routine pre-donation screening. The intra-assay agreement further demonstrates the accuracy of the device.
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spelling pubmed-96891732022-11-25 Horiba Micros ES 60 Blood Cell Analyzer in Blood Donor Eligibility: A Validation Study Tillati, Silvia Pati, Ilaria Delle Donne, Michela Meneghel, Alessandra Londero, Donatella De Angelis, Vincenzo Diagnostics (Basel) Article Background: Eligibility criteria for blood donation require hemoglobin levels of ≥12.5 g/dL for women and ≥13.5 g/dL for men, and a platelet count of ≥180 × 109/L. Screening methods before donation should ensure high accuracy, precision, and ease in operation. We assessed the performance, precision, and repeatability of the Horiba Micros ES 60 (Horiba) compared to the Beckman Coulter DXH 800. Methods: Performance was compared by testing samples for each of the 11 devices across 6 sites in the Transfusion Service of Friuli Venezia Giulia Region, Italy. We measured precision by calculating the coefficient of variation (CV), concordance with ρ-Pearson’s correlation coefficient, and accuracy with F-tests. The intra-assay agreement was examined in the 11 devices, and repeatability was performed by using CV and the Kruskal–Wallis test. Results: The precision of Horiba was acceptable. Overall, ρ-Pearson’s coefficients indicated a strong correlation and positive relationship between all variables. The Bland–Altman plots showed that most of the differences lay within the limits of agreement. All CV were below the reference threshold for all the parameters. Finally, the Kruskal–Wallis test reported non-significant statistical differences for all parameters, except platelet count (p < 0.000). Conclusions: Horiba is adequate for routine pre-donation screening. The intra-assay agreement further demonstrates the accuracy of the device. MDPI 2022-10-25 /pmc/articles/PMC9689173/ /pubmed/36359430 http://dx.doi.org/10.3390/diagnostics12112586 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Tillati, Silvia
Pati, Ilaria
Delle Donne, Michela
Meneghel, Alessandra
Londero, Donatella
De Angelis, Vincenzo
Horiba Micros ES 60 Blood Cell Analyzer in Blood Donor Eligibility: A Validation Study
title Horiba Micros ES 60 Blood Cell Analyzer in Blood Donor Eligibility: A Validation Study
title_full Horiba Micros ES 60 Blood Cell Analyzer in Blood Donor Eligibility: A Validation Study
title_fullStr Horiba Micros ES 60 Blood Cell Analyzer in Blood Donor Eligibility: A Validation Study
title_full_unstemmed Horiba Micros ES 60 Blood Cell Analyzer in Blood Donor Eligibility: A Validation Study
title_short Horiba Micros ES 60 Blood Cell Analyzer in Blood Donor Eligibility: A Validation Study
title_sort horiba micros es 60 blood cell analyzer in blood donor eligibility: a validation study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9689173/
https://www.ncbi.nlm.nih.gov/pubmed/36359430
http://dx.doi.org/10.3390/diagnostics12112586
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