Parker Megan, Han Zhen, Abu-Haydar Elizabeth, Matsiko Eric, Iyakaremye Damien, Tuyisenge Lisine, Magaret Amalia, Lyambabaje Alexandre
Nutrition Innovation, PATH, Seattle, Washington, United States of America.
Devices and Tools, PATH, Seattle, Washington, United States of America.
PLoS One. 2018 Jan 4;13(1):e0187663. doi: 10.1371/journal.pone.0187663. eCollection 2018.
Blood hemoglobin (Hb) is a common indicator for diagnosing anemia and is often determined through laboratory analysis of venous samples. One alternative to laboratory-based methods is the handheld HemoCue® Hb 201+ device, which requires a finger prick and wicking of blood into a pretreated cuvette for analysis. An alternative HemoCue® gravity method is being investigated for improved accuracy. Further, recent developments in noninvasive technologies could provide an accurate, rapid, safe, point-of-care option for hemoglobin estimation while addressing some limitations of current tools, but device performance must be assessed in low-resource settings. This study evaluated the performance of two HemoCue® Hb 201+ blood sampling methods and a noninvasive device (Pronto® with DCI-mini™ sensors) in a Rwandan pediatric clinic. Reference hemoglobin values were determined in 132 children 6 to 59 months of age by using a standard hematology analyzer (Sysmex KN21TM). Half were tested using the HemoCue® wicking method; half were tested using the HemoCue® gravity method; and 112 had successful hemoglobin readings with Pronto® DCI-mini™. Statistical analysis was used to assess the level of bias generated by each method and the key drivers of bias. The HemoCue® gravity method was the least biased. The HemoCue® wicking and Pronto® methods biases were inversely related to the Sysmex KN21TM results. Both HemoCue® sampling methods correctly classified patients' anemic status in 80% or more of instances, whereas the Pronto® device had a correct classification rate of only 69%. The HemoCue® gravity method was more accurate than the traditional HemoCue® wicking method in this study, but its accuracy and operational feasibility should be confirmed by future studies. The Pronto® DCI-mini™ devices showed considerable promise but require further improvements in sensitivity and specificity before wider adoption.
血液血红蛋白（Hb）是诊断贫血的常用指标，通常通过对静脉样本进行实验室分析来测定。基于实验室的方法的一种替代方法是手持式HemoCue®Hb 201+设备，它需要用手指采血并将血液吸到预处理过的比色杯中进行分析。正在研究一种替代的HemoCue®重力法以提高准确性。此外，无创技术的最新进展可以为血红蛋白估计提供一种准确、快速、安全的即时检测选项，同时解决当前工具的一些局限性，但设备性能必须在资源匮乏的环境中进行评估。本研究在卢旺达一家儿科诊所评估了两种HemoCue®Hb 201+采血方法和一种无创设备（带有DCI-mini™传感器的Pronto®）的性能。通过使用标准血液分析仪（Sysmex KN21TM）在132名6至59个月大的儿童中测定参考血红蛋白值。一半儿童使用HemoCue®吸液法进行测试；一半儿童使用HemoCue®重力法进行测试；112名儿童使用Pronto®DCI-mini™成功读取了血红蛋白值。使用统计分析来评估每种方法产生的偏差水平以及偏差的关键驱动因素。HemoCue®重力法偏差最小。HemoCue®吸液法和Pronto®法的偏差与Sysmex KN21TM结果呈负相关。两种HemoCue®采样方法在80%或更多的情况下正确分类了患者的贫血状态，而Pronto®设备的正确分类率仅为69%。在本研究中，HemoCue®重力法比传统的HemoCue®吸液法更准确，但其准确性和操作可行性应通过未来的研究来确认。Pronto®DCI-mini™设备显示出相当大的前景，但在更广泛应用之前需要进一步提高灵敏度和特异性。
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