Duke Global Health Institute, Duke University.
Miller School of Medicine, Miami University, US.
Ann Glob Health. 2018 Nov 5;84(4):618-624. 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.
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.
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.
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.
Imprecision and bias were not low enough to recommend either POC analyzer for HbA1c determinations in this setting.
全球范围内估计有 1.74 亿例未确诊的糖尿病病例，其中 80%发生在中低收入国家，因此有效的即时检测诊断工具是应对这一全球流行疾病的关键。糖化血红蛋白已成为诊断和预测糖尿病的可靠生物标志物。
我们评估了两种即时检测（POC）分析仪在秘鲁亚马逊雨林多民族社区中的应用情况，该地区无法进行实验室糖化血红蛋白（HbA1c）检测。
对 203 份静脉血样本同时使用 Afinion 和 DCA Vantage 分析仪以及 Premier Hb9210 高效液相色谱（HPLC）方法进行 HbA1c 检测，以 HPLC 方法为参考标准。计算每个设备的变异系数（CV），以评估检测不精密度。使用 Bland-Altman 图评估偏倚。还使用多元回归评估环境温度、湿度和气压对 HbA1c 结果的影响。
根据 HPLC 检测结果，参与者的 HbA1c 范围很广：4.4-9.0%（25-75 mmol/mol）。Afinion 的 CV 为 1.75%，Vantage 为 4.01%。Afinion 比 HPLC 生成的 HbA1c 结果更高（平均差异=+0.56%[+6 mmol/mol]；p < 0.001），DCA Vantage 也是如此（平均差异=+0.32%[4 mmol/mol]；p < 0.001）。温度和湿度与 HbA1c 无关；然而，气压与 Afinion 的 HPLC HbA1c 结果相关。
在这种情况下，两种 POC 分析仪的不精密度和偏倚均不低，不建议用于 HbA1c 测定。
