PATH, Seattle, Washington, United States of America.
Akendi, Ottawa, Ontario, Canada.
PLoS One. 2020 Mar 12;15(3):e0230333. doi: 10.1371/journal.pone.0230333. eCollection 2020.
In low- and middle-income countries, many women experience anemia during pregnancy due to insufficient dietary intake of key micronutrients, parasitic infections, hemoglobinopathies, and chronic infections. Maternal anemia increases perinatal risks for both mothers and infants, and slow progress to reduce the prevalence may be due in part to the lack of affordable tools to quantify hemoglobin levels in antenatal care (ANC) clinics. A simple, inexpensive, accurate, and robust diagnostic is needed to measure hemoglobin in ANC. This study evaluated the performance and usability of the TrueHb Hemometer. A cross-sectional diagnostic accuracy study was conducted to compare the accuracy of the TrueHb and the HemoCue® 201+ using capillary samples. Next, analytical performance (precision, coefficient of variation, R2) of the TrueHb was evaluated in varying environmental conditions using linearity panels with serial dilutions of venous blood samples. Lastly, the usability of the TrueHb Hemometer was assessed across three domains (effectiveness, efficiency, and satisfaction) by 20 ANC providers in Ghana. Capillary blood test results were not well correlated (R2 = 0.35) between the TrueHB and HemoCue201+, but 80% of TrueHb measurements were within +/-1.0 g/dl of the HemoCue® 201+ hemoglobin values. Precision tests indicated similar mean values across the three environmental conditions (CV<6%). At 21°C, the TrueHb follows a linear relationship (R2≥0.96) but does not generate accurate readings below 4.0 g/dl. At 30°C and 37°C, the TrueHb follows a linear relationship (R2 > 0.90) but begins to underestimate the hemoglobin concentration below 7.0 g/dl. The usability study identified potential failure modes due to inadequate instructions and device feedback. With some modifications, both to the product and to the instructions for use, the TrueHb may be suitable for use in ANC settings to help fill the diagnostic gap for anemia screening during pregnancy. Further testing is required with anemic populations in LMIC settings.
在中低收入国家，由于关键微量营养素摄入不足、寄生虫感染、血红蛋白病和慢性感染，许多孕妇在怀孕期间会出现贫血。孕妇贫血会增加母婴围产期风险，而减少贫血患病率的进展缓慢，部分原因可能是缺乏在产前保健 (ANC) 诊所定量血红蛋白水平的经济实惠工具。需要一种简单、廉价、准确和稳健的诊断方法来测量 ANC 中的血红蛋白。本研究评估了 TrueHb Hemometer 的性能和可用性。进行了一项横断面诊断准确性研究，以比较 TrueHb 和 HemoCue® 201+ 使用毛细血管样本的准确性。接下来，使用静脉血样本的线性面板评估了 TrueHb 在不同环境条件下的分析性能（精密度、变异系数、R2）。最后，20 名加纳 ANC 提供者在三个领域（有效性、效率和满意度）评估了 TrueHb Hemometer 的可用性。TrueHB 和 HemoCue201+ 之间的毛细血管血检测结果相关性不佳（R2 = 0.35），但 80%的 TrueHb 测量值与 HemoCue® 201+ 血红蛋白值相差 1.0 g/dl 以内。精密度测试表明在三种环境条件下具有相似的平均值（CV<6%）。在 21°C 时，TrueHb 呈线性关系（R2≥0.96），但在 4.0 g/dl 以下不会产生准确读数。在 30°C 和 37°C 时，TrueHb 呈线性关系（R2 > 0.90），但开始低估 7.0 g/dl 以下的血红蛋白浓度。可用性研究确定了由于缺乏使用说明和设备反馈而导致的潜在故障模式。通过对产品和使用说明进行一些修改，TrueHb 可能适合在 ANC 环境中使用，以帮助填补妊娠期间贫血筛查的诊断空白。需要在中低收入国家的贫血人群中进行进一步测试。
