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

• Published in: Annals of global health Vol. 84; no. 4; p. 618
• Main Authors: Saxton, Anthony T, Miranda, J Jaime, Ortiz, Ernesto J, Pan, William
• Format: Journal Article
• Language: English
• Published: 05.11.2018
• ISSN: 2214-9996; 2214-9996
• DOI: 10.9204/aogh.2368

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.BACKGROUNDWith 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.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.OBJECTIVEWe 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.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.METHODS203 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.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.FINDINGSThere 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.Imprecision and bias were not low enough to recommend either POC analyzer for HbA1c determinations in this setting.CONCLUSIONSImprecision and bias were not low enough to recommend either POC analyzer for HbA1c determinations in this setting.