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

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

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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 3 Piece King Storage Bed 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 Addition results for the Afinion.Conclusions: Imprecision and bias were not low enough to recommend either POC analyzer for HbA1c determinations in this setting.