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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,...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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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. |
format | Online Article Text |
id | pubmed-9689173 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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