Title
Assessment of two diabetes point-of-care analyzers measuring hemoglobin A1c in the peruvian amazon
Date Issued
05 November 2018
Access level
open access
Resource Type
journal article
Author(s)
Saxton A.T.
Ortiz E.J.
Pan W.
CRÓNICAS, Centro de Excelencia en Enfermedades Crónicas
Publisher(s)
Ubiquity Press
Abstract
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.
Start page
618
End page
624
Volume
84
Issue
4
Language
English
OCDE Knowledge area
Políticas de salud, Servicios de salud Endocrinología, Metabolismo (incluyendo diabetes, hormonas)
Scopus EID
2-s2.0-85061848983
PubMed ID
Source
Annals of Global Health
ISSN of the container
22149996
Sponsor(s)
Special thanks go to all of the participants of this study, Rachel Meyer and the members of the Duke Clergy Health Initiative for loaning Afinion instruments that were used in this study, Dr. Joseph Egger for statistical support, Axel Berky and Justin Lana for GIS graphical support, and to Jean Pierre Muro Guerrero, Sarah Nuss, and Madison Krischak for help processing samples in the laboratory. Funding for this study was provided by grants from the Duke Global Health Institute, Duke University Center for International Studies (DUCIS), the Duke University Center for Latin American and Caribbean Studies (CLACS), and Hunt Oil, LLC. Siemens Medical Solutions Diagnostics USA provided a DCA Vantage instrument used in this study. The funders and producers of the devices used in this study had no role in study design, data collection and analysis, interpretation, decision to publish, or preparation of the manuscript. Duke Global Health Institute, Duke University
Sources of information: Directorio de Producción Científica Scopus