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Validation of the New MINI-CUBE for Clinic Determination of Erythrocyte Sedimentation Rate

BACKGROUND: Erythrocyte sedimentation rate (ESR) indirectly measures blood fibrinogen, and it is altered by all those pathological conditions that modify the aggregation of red blood cells. The international guidelines by the International Council for Standardization in Hematology (ICSH) define the...

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Autores principales: Tomassetti, Flaminia, Pelagalli, Martina, Nicolai, Eleonora, Sarubbi, Serena, Calabrese, Cinzia, Giovannelli, Alfredo, Codella, Silvia, Viola, Gemma, Diamanti, Daniela, Massoud, Renato, Bernardini, Sergio, Pieri, Massimo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elmer Press 2023
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Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10627362/
https://www.ncbi.nlm.nih.gov/pubmed/37936975
http://dx.doi.org/10.14740/jh1165
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author Tomassetti, Flaminia
Pelagalli, Martina
Nicolai, Eleonora
Sarubbi, Serena
Calabrese, Cinzia
Giovannelli, Alfredo
Codella, Silvia
Viola, Gemma
Diamanti, Daniela
Massoud, Renato
Bernardini, Sergio
Pieri, Massimo
author_facet Tomassetti, Flaminia
Pelagalli, Martina
Nicolai, Eleonora
Sarubbi, Serena
Calabrese, Cinzia
Giovannelli, Alfredo
Codella, Silvia
Viola, Gemma
Diamanti, Daniela
Massoud, Renato
Bernardini, Sergio
Pieri, Massimo
author_sort Tomassetti, Flaminia
collection PubMed
description BACKGROUND: Erythrocyte sedimentation rate (ESR) indirectly measures blood fibrinogen, and it is altered by all those pathological conditions that modify the aggregation of red blood cells. The international guidelines by the International Council for Standardization in Hematology (ICSH) define the Westergren method as the gold standard for ESR, although it is completely operator-dependent, time-consuming, and requires a patient’s blood consumption. Therefore, the validation of new ESR analyzers is needed. The aim of this study is the validation of a new automated ESR analyzer, MINI-CUBE (DIESSE, Diagnostica Senese, Italy). METHODS: The samples (n = 270) were collected at the University Hospital of the University of Rome Tor Vergata. A comparison between the automated instrument and the gold standard was performed. Statistical analyses were processed by MedCalc software. RESULTS: The comparison analysis performed on the overall samples reported a good agreement, showing a Spearman rank correlation coefficient of 0.94 (P < 0.001), compared to the Westergren test. The Bland-Altman analysis showed a mean bias of 1.5 (maximum (max.):19.6; minimum (min.): -16.6). Inter-run (level 1 coefficient of variation (CV): 4.9%; level 2 CV: 0.8%), intra-run (level 1 CV: 21.1%; level 2 CV: 3.2%), and inter-instrument (level 1 CV: 27.1%; level 2 CV: 5.6%) precision were also assessed. The hematocrit value did not interfere with the analysis: Spearman rank correlation coefficient of 0.929 (P < 0.001); mean bias of 1.3 (max.:18.3; min.: -15.6). CONCLUSIONS: Overall results from MINI-CUBE asserted a good correlation rate with the gold standard, and it could be considered an accurate, and objective alternative for the Westergren test.
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spelling pubmed-106273622023-11-07 Validation of the New MINI-CUBE for Clinic Determination of Erythrocyte Sedimentation Rate Tomassetti, Flaminia Pelagalli, Martina Nicolai, Eleonora Sarubbi, Serena Calabrese, Cinzia Giovannelli, Alfredo Codella, Silvia Viola, Gemma Diamanti, Daniela Massoud, Renato Bernardini, Sergio Pieri, Massimo J Hematol Original Article BACKGROUND: Erythrocyte sedimentation rate (ESR) indirectly measures blood fibrinogen, and it is altered by all those pathological conditions that modify the aggregation of red blood cells. The international guidelines by the International Council for Standardization in Hematology (ICSH) define the Westergren method as the gold standard for ESR, although it is completely operator-dependent, time-consuming, and requires a patient’s blood consumption. Therefore, the validation of new ESR analyzers is needed. The aim of this study is the validation of a new automated ESR analyzer, MINI-CUBE (DIESSE, Diagnostica Senese, Italy). METHODS: The samples (n = 270) were collected at the University Hospital of the University of Rome Tor Vergata. A comparison between the automated instrument and the gold standard was performed. Statistical analyses were processed by MedCalc software. RESULTS: The comparison analysis performed on the overall samples reported a good agreement, showing a Spearman rank correlation coefficient of 0.94 (P < 0.001), compared to the Westergren test. The Bland-Altman analysis showed a mean bias of 1.5 (maximum (max.):19.6; minimum (min.): -16.6). Inter-run (level 1 coefficient of variation (CV): 4.9%; level 2 CV: 0.8%), intra-run (level 1 CV: 21.1%; level 2 CV: 3.2%), and inter-instrument (level 1 CV: 27.1%; level 2 CV: 5.6%) precision were also assessed. The hematocrit value did not interfere with the analysis: Spearman rank correlation coefficient of 0.929 (P < 0.001); mean bias of 1.3 (max.:18.3; min.: -15.6). CONCLUSIONS: Overall results from MINI-CUBE asserted a good correlation rate with the gold standard, and it could be considered an accurate, and objective alternative for the Westergren test. Elmer Press 2023-10 2023-10-25 /pmc/articles/PMC10627362/ /pubmed/37936975 http://dx.doi.org/10.14740/jh1165 Text en Copyright 2023, Tomassetti et al. https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution Non-Commercial 4.0 International License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Tomassetti, Flaminia
Pelagalli, Martina
Nicolai, Eleonora
Sarubbi, Serena
Calabrese, Cinzia
Giovannelli, Alfredo
Codella, Silvia
Viola, Gemma
Diamanti, Daniela
Massoud, Renato
Bernardini, Sergio
Pieri, Massimo
Validation of the New MINI-CUBE for Clinic Determination of Erythrocyte Sedimentation Rate
title Validation of the New MINI-CUBE for Clinic Determination of Erythrocyte Sedimentation Rate
title_full Validation of the New MINI-CUBE for Clinic Determination of Erythrocyte Sedimentation Rate
title_fullStr Validation of the New MINI-CUBE for Clinic Determination of Erythrocyte Sedimentation Rate
title_full_unstemmed Validation of the New MINI-CUBE for Clinic Determination of Erythrocyte Sedimentation Rate
title_short Validation of the New MINI-CUBE for Clinic Determination of Erythrocyte Sedimentation Rate
title_sort validation of the new mini-cube for clinic determination of erythrocyte sedimentation rate
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10627362/
https://www.ncbi.nlm.nih.gov/pubmed/37936975
http://dx.doi.org/10.14740/jh1165
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