Assessment of Two Diabetes Point-of-care Analyzers Measuring Hemoglobin A1c in the Peruvian Amazon

Background: With an estimated 174 million undiagnosed cases of diabetes mellitus worldwide and 80% of them occurring in low- and middle-income countries an effective point-of-care diagnostic tool is key to fighting this global epidemic. Glycated hemoglobin has become a reliable biomarker for the dia...

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Autores principales:	Anthony T. Saxton, J. Jaime Miranda, Ernesto J. Ortiz, William Pan
Formato:	article
Lenguaje:	EN
Publicado:	Ubiquity Press 2018
Materias:	Infectious and parasitic diseases RC109-216 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/01254071bbde4e4993a610d3b7db1024
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spelling	oai:doaj.org-article:01254071bbde4e4993a610d3b7db10242021-12-02T02:59:06ZAssessment of Two Diabetes Point-of-care Analyzers Measuring Hemoglobin A1c in the Peruvian Amazon2214-999610.29024/aogh.2368https://doaj.org/article/01254071bbde4e4993a610d3b7db10242018-11-01T00:00:00Zhttps://annalsofglobalhealth.org/articles/2368https://doaj.org/toc/2214-9996Background: With an estimated 174 million undiagnosed cases of diabetes mellitus worldwide and 80% of them occurring in low- and middle-income countries an effective point-of-care diagnostic tool is key to fighting this global epidemic. Glycated hemoglobin has become a reliable biomarker for the diagnosis and prognosis of diabetes. Objective: We assessed two point-of-care (POC) analyzers in multi-ethnic communities of the Amazon Rainforest in Peru where laboratory-based glycated hemoglobin (HbA1c) testing is not available. Methods: 203 venous blood samples were tested for HbA1c by Afinion and DCA Vantage analyzers as well as a Premier Hb9210 high-performance liquid chromatography (HPLC) method as the reference standard. The coefficient of variation (CV) of each device was calculated to assess assay imprecision. Bland-Altman plots were used to assess bias. Ambient temperature, humidity, and barometric pressure were also evaluated for their effect on HbA1c results using multivariate regression. Findings: There was a wide range of HbA1c for participants based on the HPLC test: 4.4–9.0% (25–75 mmol/mol). The CV for the Afinion was 1.75%, and 4.01% for Vantage. The Afinion generated higher HbA1c results than the HPLC (mean difference = +0.56% [+6 mmol/mol]; p < 0.001), as did the DCA Vantage (mean difference = +0.32% [4 mmol/mol] p < 0.001). Temperature and humidity were not related to HbA1c; however, barometric pressure was associated with HPLC HbA1c results for the Afinion. Conclusions: Imprecision and bias were not low enough to recommend either POC analyzer for HbA1c determinations in this setting.Anthony T. SaxtonJ. Jaime MirandaErnesto J. OrtizWilliam PanUbiquity PressarticleInfectious and parasitic diseasesRC109-216Public aspects of medicineRA1-1270ENAnnals of Global Health, Vol 84, Iss 4 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Infectious and parasitic diseases RC109-216 Public aspects of medicine RA1-1270
spellingShingle	Infectious and parasitic diseases RC109-216 Public aspects of medicine RA1-1270 Anthony T. Saxton J. Jaime Miranda Ernesto J. Ortiz William Pan Assessment of Two Diabetes Point-of-care Analyzers Measuring Hemoglobin A1c in the Peruvian Amazon
description	Background: With an estimated 174 million undiagnosed cases of diabetes mellitus worldwide and 80% of them occurring in low- and middle-income countries an effective point-of-care diagnostic tool is key to fighting this global epidemic. Glycated hemoglobin has become a reliable biomarker for the diagnosis and prognosis of diabetes. Objective: We assessed two point-of-care (POC) analyzers in multi-ethnic communities of the Amazon Rainforest in Peru where laboratory-based glycated hemoglobin (HbA1c) testing is not available. Methods: 203 venous blood samples were tested for HbA1c by Afinion and DCA Vantage analyzers as well as a Premier Hb9210 high-performance liquid chromatography (HPLC) method as the reference standard. The coefficient of variation (CV) of each device was calculated to assess assay imprecision. Bland-Altman plots were used to assess bias. Ambient temperature, humidity, and barometric pressure were also evaluated for their effect on HbA1c results using multivariate regression. Findings: There was a wide range of HbA1c for participants based on the HPLC test: 4.4–9.0% (25–75 mmol/mol). The CV for the Afinion was 1.75%, and 4.01% for Vantage. The Afinion generated higher HbA1c results than the HPLC (mean difference = +0.56% [+6 mmol/mol]; p < 0.001), as did the DCA Vantage (mean difference = +0.32% [4 mmol/mol] p < 0.001). Temperature and humidity were not related to HbA1c; however, barometric pressure was associated with HPLC HbA1c results for the Afinion. Conclusions: Imprecision and bias were not low enough to recommend either POC analyzer for HbA1c determinations in this setting.
format	article
author	Anthony T. Saxton J. Jaime Miranda Ernesto J. Ortiz William Pan
author_facet	Anthony T. Saxton J. Jaime Miranda Ernesto J. Ortiz William Pan
author_sort	Anthony T. Saxton
title	Assessment of Two Diabetes Point-of-care Analyzers Measuring Hemoglobin A1c in the Peruvian Amazon
title_short	Assessment of Two Diabetes Point-of-care Analyzers Measuring Hemoglobin A1c in the Peruvian Amazon
title_full	Assessment of Two Diabetes Point-of-care Analyzers Measuring Hemoglobin A1c in the Peruvian Amazon
title_fullStr	Assessment of Two Diabetes Point-of-care Analyzers Measuring Hemoglobin A1c in the Peruvian Amazon
title_full_unstemmed	Assessment of Two Diabetes Point-of-care Analyzers Measuring Hemoglobin A1c in the Peruvian Amazon
title_sort	assessment of two diabetes point-of-care analyzers measuring hemoglobin a1c in the peruvian amazon
publisher	Ubiquity Press
publishDate	2018
url	https://doaj.org/article/01254071bbde4e4993a610d3b7db1024
work_keys_str_mv	AT anthonytsaxton assessmentoftwodiabetespointofcareanalyzersmeasuringhemoglobina1cintheperuvianamazon AT jjaimemiranda assessmentoftwodiabetespointofcareanalyzersmeasuringhemoglobina1cintheperuvianamazon AT ernestojortiz assessmentoftwodiabetespointofcareanalyzersmeasuringhemoglobina1cintheperuvianamazon AT williampan assessmentoftwodiabetespointofcareanalyzersmeasuringhemoglobina1cintheperuvianamazon
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Assessment of Two Diabetes Point-of-care Analyzers Measuring Hemoglobin A1c in the Peruvian Amazon

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