Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study
Autor(a) principal: | |
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Data de Publicação: | 2015 |
Outros Autores: | , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | São Paulo medical journal (Online) |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-31802015000600460 |
Resumo: | CONTEXT AND OBJECTIVE: To monitor glycemic control in diabetic patients, regular measurement of glycated hemoglobin (HbA1c) is recommended, but this can be difficult in remote places without access to laboratories. Portable point-of-care testing devices can prove a useful alternative. Our study aimed to assess the performance of one of them: A1CNow+, from Bayer. DESIGN AND SETTING: Cross-sectional accuracy study conducted at a university hospital in Brazil. METHODS: We made three successive measurements of capillary HbA1c using the A1CNow+ in 55 diabetic volunteers, while the same measurement was made on venous blood using the hospital reference method (Vitros 5,1 FS). We used the Bland-Altman graphical method to assess the A1CNow+ in relation to the Vitros 5,1 FS method. We also evaluated clinical usefulness by calculating the sensitivity and specificity of A1CNow+ for detecting patients with HbA1c lower than 7%, which is the usual limit for good glycemic control. RESULTS: The coefficient of variation between repeat testing for the A1CNow+ was 3.6%. The mean difference between A1CNow+ and Vitros 5,1 FS was +0.67% (95% confidence interval, CI: +0.52 to +0.81). The agreement limits of our Bland-Altman graph were -0.45 (95% CI: -0.71 to -0.19) and +1.82 (95% CI: +1.52 to +2.05). The sensitivity and specificity in relation to the 7% limit were respectively 100% and 67.7%. CONCLUSIONS: Although the A1CNow+ had good sensitivity, its accuracy was insufficient for use as a replacement for laboratory measurements of HbA1c, for glycemic control monitoring in diabetic patients. |
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São Paulo medical journal (Online) |
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Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy studyHemoglobin A, glycosylatedPoint-of-care systemsTechnology assessment, biomedicalDiabetes mellitusPrimary health care CONTEXT AND OBJECTIVE: To monitor glycemic control in diabetic patients, regular measurement of glycated hemoglobin (HbA1c) is recommended, but this can be difficult in remote places without access to laboratories. Portable point-of-care testing devices can prove a useful alternative. Our study aimed to assess the performance of one of them: A1CNow+, from Bayer. DESIGN AND SETTING: Cross-sectional accuracy study conducted at a university hospital in Brazil. METHODS: We made three successive measurements of capillary HbA1c using the A1CNow+ in 55 diabetic volunteers, while the same measurement was made on venous blood using the hospital reference method (Vitros 5,1 FS). We used the Bland-Altman graphical method to assess the A1CNow+ in relation to the Vitros 5,1 FS method. We also evaluated clinical usefulness by calculating the sensitivity and specificity of A1CNow+ for detecting patients with HbA1c lower than 7%, which is the usual limit for good glycemic control. RESULTS: The coefficient of variation between repeat testing for the A1CNow+ was 3.6%. The mean difference between A1CNow+ and Vitros 5,1 FS was +0.67% (95% confidence interval, CI: +0.52 to +0.81). The agreement limits of our Bland-Altman graph were -0.45 (95% CI: -0.71 to -0.19) and +1.82 (95% CI: +1.52 to +2.05). The sensitivity and specificity in relation to the 7% limit were respectively 100% and 67.7%. CONCLUSIONS: Although the A1CNow+ had good sensitivity, its accuracy was insufficient for use as a replacement for laboratory measurements of HbA1c, for glycemic control monitoring in diabetic patients.Associação Paulista de Medicina - APM2015-12-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-31802015000600460Sao Paulo Medical Journal v.133 n.6 2015reponame:São Paulo medical journal (Online)instname:Associação Paulista de Medicinainstacron:APM10.1590/1516-3180.2013.9110911info:eu-repo/semantics/openAccessAffret,AurélieGriz,Luiz Henrique MacielCesse,Eduarda Ângela PessoaSpecht,Yuri da SilvaCarvalho,Eduardo Maia Freese deFontbonne,Annickeng2016-01-06T00:00:00Zoai:scielo:S1516-31802015000600460Revistahttp://www.scielo.br/spmjhttps://old.scielo.br/oai/scielo-oai.phprevistas@apm.org.br1806-94601516-3180opendoar:2016-01-06T00:00São Paulo medical journal (Online) - Associação Paulista de Medicinafalse |
dc.title.none.fl_str_mv |
Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study |
title |
Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study |
spellingShingle |
Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study Affret,Aurélie Hemoglobin A, glycosylated Point-of-care systems Technology assessment, biomedical Diabetes mellitus Primary health care |
title_short |
Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study |
title_full |
Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study |
title_fullStr |
Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study |
title_full_unstemmed |
Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study |
title_sort |
Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study |
author |
Affret,Aurélie |
author_facet |
Affret,Aurélie Griz,Luiz Henrique Maciel Cesse,Eduarda Ângela Pessoa Specht,Yuri da Silva Carvalho,Eduardo Maia Freese de Fontbonne,Annick |
author_role |
author |
author2 |
Griz,Luiz Henrique Maciel Cesse,Eduarda Ângela Pessoa Specht,Yuri da Silva Carvalho,Eduardo Maia Freese de Fontbonne,Annick |
author2_role |
author author author author author |
dc.contributor.author.fl_str_mv |
Affret,Aurélie Griz,Luiz Henrique Maciel Cesse,Eduarda Ângela Pessoa Specht,Yuri da Silva Carvalho,Eduardo Maia Freese de Fontbonne,Annick |
dc.subject.por.fl_str_mv |
Hemoglobin A, glycosylated Point-of-care systems Technology assessment, biomedical Diabetes mellitus Primary health care |
topic |
Hemoglobin A, glycosylated Point-of-care systems Technology assessment, biomedical Diabetes mellitus Primary health care |
description |
CONTEXT AND OBJECTIVE: To monitor glycemic control in diabetic patients, regular measurement of glycated hemoglobin (HbA1c) is recommended, but this can be difficult in remote places without access to laboratories. Portable point-of-care testing devices can prove a useful alternative. Our study aimed to assess the performance of one of them: A1CNow+, from Bayer. DESIGN AND SETTING: Cross-sectional accuracy study conducted at a university hospital in Brazil. METHODS: We made three successive measurements of capillary HbA1c using the A1CNow+ in 55 diabetic volunteers, while the same measurement was made on venous blood using the hospital reference method (Vitros 5,1 FS). We used the Bland-Altman graphical method to assess the A1CNow+ in relation to the Vitros 5,1 FS method. We also evaluated clinical usefulness by calculating the sensitivity and specificity of A1CNow+ for detecting patients with HbA1c lower than 7%, which is the usual limit for good glycemic control. RESULTS: The coefficient of variation between repeat testing for the A1CNow+ was 3.6%. The mean difference between A1CNow+ and Vitros 5,1 FS was +0.67% (95% confidence interval, CI: +0.52 to +0.81). The agreement limits of our Bland-Altman graph were -0.45 (95% CI: -0.71 to -0.19) and +1.82 (95% CI: +1.52 to +2.05). The sensitivity and specificity in relation to the 7% limit were respectively 100% and 67.7%. CONCLUSIONS: Although the A1CNow+ had good sensitivity, its accuracy was insufficient for use as a replacement for laboratory measurements of HbA1c, for glycemic control monitoring in diabetic patients. |
publishDate |
2015 |
dc.date.none.fl_str_mv |
2015-12-01 |
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=S1516-31802015000600460 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-31802015000600460 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.1590/1516-3180.2013.9110911 |
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 |
Associação Paulista de Medicina - APM |
publisher.none.fl_str_mv |
Associação Paulista de Medicina - APM |
dc.source.none.fl_str_mv |
Sao Paulo Medical Journal v.133 n.6 2015 reponame:São Paulo medical journal (Online) instname:Associação Paulista de Medicina instacron:APM |
instname_str |
Associação Paulista de Medicina |
instacron_str |
APM |
institution |
APM |
reponame_str |
São Paulo medical journal (Online) |
collection |
São Paulo medical journal (Online) |
repository.name.fl_str_mv |
São Paulo medical journal (Online) - Associação Paulista de Medicina |
repository.mail.fl_str_mv |
revistas@apm.org.br |
_version_ |
1754209264484745216 |