Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium®
Autor(a) principal: | |
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Data de Publicação: | 2018 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Jornal Brasileiro de Patologia e Medicina Laboratorial (Online) |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1676-24442018000300158 |
Resumo: | ABSTRACT Introduction: The harmonization of equipment is recommended in clinical laboratory practice aiming for the homogeneity of results when similar or equivalent analyzers are used to perform routine testing. Objectives: To conduct a study of equivalence between the biochemical analyzers Labmax 240® (E1) and Labmax 240 Premium® (E2) through the matching results and the statistical value analysis of dosages. Materials and methods: We evaluated tests with glucose, total cholesterol, triglycerides, uric acid, aspartate transaminase (AST), alanine transaminase (ALT) and lactate dehydrogenase (LDH), all with 40 repeated measurements, performed in both equipments. The Clinical and Laboratory Standards Institute (CLSI) EP09-3A protocol was used to conduct the comparison test between E1 and E2 equipment, with subsequent evaluation of the results for statistical analysis determining the Pearson correlation coefficient (r) and indexes comparison error with EP Evaluator® software. Results: Regarding the values of the Pearson correlation coefficient, all tests showed a strong correlation between equipment with r > 0.989, except for the dosage of LDH (r = 0.982). This dosage failed not because the value of r, but due to the values obtained in the error index being larger than the total errors index allowed. Discussion: Compared to clinical criteria, the results of the analyzers are approximately equal, but this control process must be done continuously in order to prevent and track random errors within the laboratory routine. Conclusion: The process of harmonization of multiple devices that perform the same laboratory parameters is essential for ensuring quality and reliability of laboratory results and should be standardized and included in routine clinical analysis laboratories. |
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Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium®quality controlquality assurance health carelaboratory equipmentautomation laboratoryABSTRACT Introduction: The harmonization of equipment is recommended in clinical laboratory practice aiming for the homogeneity of results when similar or equivalent analyzers are used to perform routine testing. Objectives: To conduct a study of equivalence between the biochemical analyzers Labmax 240® (E1) and Labmax 240 Premium® (E2) through the matching results and the statistical value analysis of dosages. Materials and methods: We evaluated tests with glucose, total cholesterol, triglycerides, uric acid, aspartate transaminase (AST), alanine transaminase (ALT) and lactate dehydrogenase (LDH), all with 40 repeated measurements, performed in both equipments. The Clinical and Laboratory Standards Institute (CLSI) EP09-3A protocol was used to conduct the comparison test between E1 and E2 equipment, with subsequent evaluation of the results for statistical analysis determining the Pearson correlation coefficient (r) and indexes comparison error with EP Evaluator® software. Results: Regarding the values of the Pearson correlation coefficient, all tests showed a strong correlation between equipment with r > 0.989, except for the dosage of LDH (r = 0.982). This dosage failed not because the value of r, but due to the values obtained in the error index being larger than the total errors index allowed. Discussion: Compared to clinical criteria, the results of the analyzers are approximately equal, but this control process must be done continuously in order to prevent and track random errors within the laboratory routine. Conclusion: The process of harmonization of multiple devices that perform the same laboratory parameters is essential for ensuring quality and reliability of laboratory results and should be standardized and included in routine clinical analysis laboratories.Sociedade Brasileira de Patologia Clínica2018-06-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1676-24442018000300158Jornal Brasileiro de Patologia e Medicina Laboratorial v.54 n.3 2018reponame:Jornal Brasileiro de Patologia e Medicina Laboratorial (Online)instname:Sociedade Brasileira de Patologia (SBP)instacron:SBP10.5935/1676-2444.20180028info:eu-repo/semantics/openAccessScapin,Luisa D.Ramos,Vanessa P.Marco,Marion deSiqueira,Rodrigo P.Tavares,Rejane G.eng2018-08-08T00:00:00Zoai:scielo:S1676-24442018000300158Revistahttp://www.scielo.br/jbpmlhttps://old.scielo.br/oai/scielo-oai.php||jbpml@sbpc.org.br1678-47741676-2444opendoar:2018-08-08T00:00Jornal Brasileiro de Patologia e Medicina Laboratorial (Online) - Sociedade Brasileira de Patologia (SBP)false |
dc.title.none.fl_str_mv |
Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium® |
title |
Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium® |
spellingShingle |
Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium® Scapin,Luisa D. quality control quality assurance health care laboratory equipment automation laboratory |
title_short |
Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium® |
title_full |
Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium® |
title_fullStr |
Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium® |
title_full_unstemmed |
Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium® |
title_sort |
Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium® |
author |
Scapin,Luisa D. |
author_facet |
Scapin,Luisa D. Ramos,Vanessa P. Marco,Marion de Siqueira,Rodrigo P. Tavares,Rejane G. |
author_role |
author |
author2 |
Ramos,Vanessa P. Marco,Marion de Siqueira,Rodrigo P. Tavares,Rejane G. |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Scapin,Luisa D. Ramos,Vanessa P. Marco,Marion de Siqueira,Rodrigo P. Tavares,Rejane G. |
dc.subject.por.fl_str_mv |
quality control quality assurance health care laboratory equipment automation laboratory |
topic |
quality control quality assurance health care laboratory equipment automation laboratory |
description |
ABSTRACT Introduction: The harmonization of equipment is recommended in clinical laboratory practice aiming for the homogeneity of results when similar or equivalent analyzers are used to perform routine testing. Objectives: To conduct a study of equivalence between the biochemical analyzers Labmax 240® (E1) and Labmax 240 Premium® (E2) through the matching results and the statistical value analysis of dosages. Materials and methods: We evaluated tests with glucose, total cholesterol, triglycerides, uric acid, aspartate transaminase (AST), alanine transaminase (ALT) and lactate dehydrogenase (LDH), all with 40 repeated measurements, performed in both equipments. The Clinical and Laboratory Standards Institute (CLSI) EP09-3A protocol was used to conduct the comparison test between E1 and E2 equipment, with subsequent evaluation of the results for statistical analysis determining the Pearson correlation coefficient (r) and indexes comparison error with EP Evaluator® software. Results: Regarding the values of the Pearson correlation coefficient, all tests showed a strong correlation between equipment with r > 0.989, except for the dosage of LDH (r = 0.982). This dosage failed not because the value of r, but due to the values obtained in the error index being larger than the total errors index allowed. Discussion: Compared to clinical criteria, the results of the analyzers are approximately equal, but this control process must be done continuously in order to prevent and track random errors within the laboratory routine. Conclusion: The process of harmonization of multiple devices that perform the same laboratory parameters is essential for ensuring quality and reliability of laboratory results and should be standardized and included in routine clinical analysis laboratories. |
publishDate |
2018 |
dc.date.none.fl_str_mv |
2018-06-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1676-24442018000300158 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1676-24442018000300158 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.5935/1676-2444.20180028 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Sociedade Brasileira de Patologia Clínica |
publisher.none.fl_str_mv |
Sociedade Brasileira de Patologia Clínica |
dc.source.none.fl_str_mv |
Jornal Brasileiro de Patologia e Medicina Laboratorial v.54 n.3 2018 reponame:Jornal Brasileiro de Patologia e Medicina Laboratorial (Online) instname:Sociedade Brasileira de Patologia (SBP) instacron:SBP |
instname_str |
Sociedade Brasileira de Patologia (SBP) |
instacron_str |
SBP |
institution |
SBP |
reponame_str |
Jornal Brasileiro de Patologia e Medicina Laboratorial (Online) |
collection |
Jornal Brasileiro de Patologia e Medicina Laboratorial (Online) |
repository.name.fl_str_mv |
Jornal Brasileiro de Patologia e Medicina Laboratorial (Online) - Sociedade Brasileira de Patologia (SBP) |
repository.mail.fl_str_mv |
||jbpml@sbpc.org.br |
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1752122297116786688 |