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From Hemophilia to Deep Venous Thrombosis Patient Samples: How to Perform an Easy Coagulometer Validation Process According to Available Guidelines

Validation protocols for the evaluation of coagulometers are needed to help professionals select the most suitable system for their regular laboratory routines. The objective of this study was to show how high standard protocols for the coagulometer validation process can fit into the daily laborato...

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Autores principales: Montalvão, Silmara Aparecida de Lima, Francisco, Ana Paula, da Silva, Bittar Letícia Queiroz, Huber, Stephany Cares, Aguiari, Helder José, Fernandes, Maria Carmem Gonçalves Lopes, Elidio, Priscila Soares, Martinelli, Beatriz de Moraes, Tony, Isa Macedo, Colella, Marina Pereira, Annichinno-Bizzachi, Joyce Maria
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427006/
https://www.ncbi.nlm.nih.gov/pubmed/32491936
http://dx.doi.org/10.1177/1076029620915512
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author Montalvão, Silmara Aparecida de Lima
Francisco, Ana Paula
da Silva, Bittar Letícia Queiroz
Huber, Stephany Cares
Aguiari, Helder José
Fernandes, Maria Carmem Gonçalves Lopes
Elidio, Priscila Soares
Martinelli, Beatriz de Moraes
Tony, Isa Macedo
Colella, Marina Pereira
Annichinno-Bizzachi, Joyce Maria
author_facet Montalvão, Silmara Aparecida de Lima
Francisco, Ana Paula
da Silva, Bittar Letícia Queiroz
Huber, Stephany Cares
Aguiari, Helder José
Fernandes, Maria Carmem Gonçalves Lopes
Elidio, Priscila Soares
Martinelli, Beatriz de Moraes
Tony, Isa Macedo
Colella, Marina Pereira
Annichinno-Bizzachi, Joyce Maria
author_sort Montalvão, Silmara Aparecida de Lima
collection PubMed
description Validation protocols for the evaluation of coagulometers are needed to help professionals select the most suitable system for their regular laboratory routines. The objective of this study was to show how high standard protocols for the coagulometer validation process can fit into the daily laboratory routine. For this study, 45 healthy individuals and 112 patient samples were analyzed. From the patient samples, 51 were investigated for deep venous thrombosis, 27 for coagulopathy, 19 for antivitamin K therapy, and 15 for hemophilia. For the assessment, the performance of the 3 coagulometers and 1 point-of-care device was considered. One of the coagulometers was a new acquisition evaluated for precision, linearity, throughput, and carryover in the first moment, and the new coagulometer was then compared with the other well-established equipment in the laboratory. In normal plasma, coefficient of variation was ≤1.8% for total precision in screening tests and ≤3.5% for within-run precision in specific assays. For prothrombin time/international normalized ratio, no significant difference was found when comparing methods. Our study showed how to compare the capacity of a reagent in order to discriminate patients with severe hemophilia from patients with moderated hemophilia, and the κ coefficient agreement was 0.669 (95% confidence interval: 0.3-1.0; P < .001). d-dimer evaluated in patients with deep venous thrombosis and controls showed a 20% discrepancy between the methods. In our experience across Latin America, the number of laboratories that has performed this process is limited. In this study, we demonstrated how to adapt the validation process for the hemostasis laboratory routine to help the professional chose the best and more suitable option.
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spelling pubmed-74270062020-08-25 From Hemophilia to Deep Venous Thrombosis Patient Samples: How to Perform an Easy Coagulometer Validation Process According to Available Guidelines Montalvão, Silmara Aparecida de Lima Francisco, Ana Paula da Silva, Bittar Letícia Queiroz Huber, Stephany Cares Aguiari, Helder José Fernandes, Maria Carmem Gonçalves Lopes Elidio, Priscila Soares Martinelli, Beatriz de Moraes Tony, Isa Macedo Colella, Marina Pereira Annichinno-Bizzachi, Joyce Maria Clin Appl Thromb Hemost Original Article Validation protocols for the evaluation of coagulometers are needed to help professionals select the most suitable system for their regular laboratory routines. The objective of this study was to show how high standard protocols for the coagulometer validation process can fit into the daily laboratory routine. For this study, 45 healthy individuals and 112 patient samples were analyzed. From the patient samples, 51 were investigated for deep venous thrombosis, 27 for coagulopathy, 19 for antivitamin K therapy, and 15 for hemophilia. For the assessment, the performance of the 3 coagulometers and 1 point-of-care device was considered. One of the coagulometers was a new acquisition evaluated for precision, linearity, throughput, and carryover in the first moment, and the new coagulometer was then compared with the other well-established equipment in the laboratory. In normal plasma, coefficient of variation was ≤1.8% for total precision in screening tests and ≤3.5% for within-run precision in specific assays. For prothrombin time/international normalized ratio, no significant difference was found when comparing methods. Our study showed how to compare the capacity of a reagent in order to discriminate patients with severe hemophilia from patients with moderated hemophilia, and the κ coefficient agreement was 0.669 (95% confidence interval: 0.3-1.0; P < .001). d-dimer evaluated in patients with deep venous thrombosis and controls showed a 20% discrepancy between the methods. In our experience across Latin America, the number of laboratories that has performed this process is limited. In this study, we demonstrated how to adapt the validation process for the hemostasis laboratory routine to help the professional chose the best and more suitable option. SAGE Publications 2020-06-03 /pmc/articles/PMC7427006/ /pubmed/32491936 http://dx.doi.org/10.1177/1076029620915512 Text en © The Author(s) 2020 https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Article
Montalvão, Silmara Aparecida de Lima
Francisco, Ana Paula
da Silva, Bittar Letícia Queiroz
Huber, Stephany Cares
Aguiari, Helder José
Fernandes, Maria Carmem Gonçalves Lopes
Elidio, Priscila Soares
Martinelli, Beatriz de Moraes
Tony, Isa Macedo
Colella, Marina Pereira
Annichinno-Bizzachi, Joyce Maria
From Hemophilia to Deep Venous Thrombosis Patient Samples: How to Perform an Easy Coagulometer Validation Process According to Available Guidelines
title From Hemophilia to Deep Venous Thrombosis Patient Samples: How to Perform an Easy Coagulometer Validation Process According to Available Guidelines
title_full From Hemophilia to Deep Venous Thrombosis Patient Samples: How to Perform an Easy Coagulometer Validation Process According to Available Guidelines
title_fullStr From Hemophilia to Deep Venous Thrombosis Patient Samples: How to Perform an Easy Coagulometer Validation Process According to Available Guidelines
title_full_unstemmed From Hemophilia to Deep Venous Thrombosis Patient Samples: How to Perform an Easy Coagulometer Validation Process According to Available Guidelines
title_short From Hemophilia to Deep Venous Thrombosis Patient Samples: How to Perform an Easy Coagulometer Validation Process According to Available Guidelines
title_sort from hemophilia to deep venous thrombosis patient samples: how to perform an easy coagulometer validation process according to available guidelines
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427006/
https://www.ncbi.nlm.nih.gov/pubmed/32491936
http://dx.doi.org/10.1177/1076029620915512
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