Saengnipanthkul Suchaorn, Tawiangnan Chamaiporn, Sirikarn Prapassara, Supasai Sakuntala, Sitthikarnkha Phanthila, Techasatian Leelawadee, Uppala Rattapon
Department of Pediatrics, Khon Kaen University Faculty of Medicine, Khon Kaen, Thailand
Department of Pediatrics, Khon Kaen University Faculty of Medicine, Khon Kaen, Thailand.
BMJ Open. 2024 Dec 30;14(12):e083356. doi: 10.1136/bmjopen-2023-083356.
Infants are at a high risk of developing anaemia, which can arise from various causes, including inappropriate feeding practices. However, few infants attend anaemia screening programmes due to poor cooperation and being time-consuming. This study evaluated the accuracy of noninvasive total haemoglobin (Hb) spot-check monitoring as part of anaemia screening in healthy infants, compared with the conventional laboratory method.
A cross-sectional study was conducted using a consecutive sampling technique.
The study was carried out at the Well-Child Clinic, Khon Kaen University, Thailand.
Healthy, full-term infants aged 6-12 months who were scheduled for vaccination. Spectrophotometric haemoglobin (SpHb) was measured using Masimo Rad-67 with Rainbow DCI-mini Sensor. These values were compared with conventional laboratory analysis (HbLab) performed on the same day.
Differences between Hb values using the two methods were analysed using the Bland-Altman method. Sensitivity, specificity and positive and negative predictive values (PPV and NPV) for detecting anaemia were determined. Anaemia was defined as HbLab of <11.0 g/dL.
A total of 104 infants, with a median age of 9.6 (IQR 9.3, 10.9) months, were included. The prevalence of anaemia, defined by HbLab, was 38.46%. The mean SpHb was 12.20±1.10 g/dL, while the mean HbLab was 11.19±1.21 g/dL. A moderate positive correlation was observed (=0.575, p<0.001). Bland-Altman analysis of SpHb vs HbLab showed an estimated bias of 1.007 g/dL with a 95% limit of agreement ranging from -1.091 to 3.104 g/dL. The mean bias was 1.635 g/dL (-0.617 to 3.887) in the anaemic group and 0.614 g/dL (-0.964 to 2.192) in the nonanaemic group. Using the SpHb cut-off point of <13.0 g/dL, the sensitivity and specificity of SpHb to detect anaemia were 95.0% and 35.9%, with PPV and NPV of 48.1% and 92.0%, respectively.
A noninvasive tool for measuring Hb, with moderate sensitivity and NPV, may provide utility for initial screening to reduce unnecessary venipuncture in infants. However, its limited specificity and PPV necessitate confirmatory testing through conventional laboratory methods for accurate diagnosis. Depending on the context and available resources, it has potential to complement existing diagnostic processes, particularly in settings where rapid and noninvasive screening is prioritised.
Thai Clinical Trials Registry (TCTR20210816002).
婴儿患贫血的风险很高，其病因多种多样，包括喂养方式不当。然而，由于配合度差和耗时，很少有婴儿参加贫血筛查项目。本研究将无创全血红蛋白（Hb）点刺监测作为健康婴儿贫血筛查的一部分，与传统实验室方法进行比较，评估其准确性。
采用连续抽样技术进行横断面研究。
研究在泰国孔敬大学儿童健康诊所开展。
计划接种疫苗的6至12个月健康足月婴儿。使用配有Rainbow DCI-mini传感器的Masimo Rad-67测量分光光度血红蛋白（SpHb）。将这些值与同一天进行的传统实验室分析（HbLab）结果进行比较。
使用Bland-Altman方法分析两种方法测得的Hb值之间的差异。确定检测贫血的敏感性、特异性以及阳性和阴性预测值（PPV和NPV）。贫血定义为HbLab<11.0 g/dL。
共纳入104名婴儿，中位年龄为9.6（四分位间距9.3，10.9）个月。根据HbLab定义的贫血患病率为38.46%。SpHb的平均值为12.20±1.10 g/dL，而HbLab的平均值为11.19±1.21 g/dL。观察到中度正相关（=0.575，p<0.001）。SpHb与HbLab的Bland-Altman分析显示估计偏差为1.007 g/dL，95%一致性界限为-1.091至3.104 g/dL。贫血组的平均偏差为1.635 g/dL（-0.617至3.887），非贫血组为0.614 g/dL（-0.964至2.192）。使用SpHb<13.0 g/dL的截断点，SpHb检测贫血的敏感性和特异性分别为95.0%和35.9%，PPV和NPV分别为48.1%和92.0%。
一种具有中度敏感性和NPV的无创Hb测量工具，可能有助于初步筛查，以减少婴儿不必要的静脉穿刺。然而，其有限的特异性和PPV需要通过传统实验室方法进行确认性检测以实现准确诊断。根据具体情况和可用资源，它有潜力补充现有的诊断流程，特别是在优先考虑快速和无创筛查的环境中。
泰国临床试验注册中心（TCTR20210816002）。
