Haramati Sharon, Firsow Anastasia, Navarro Daniela Abigail, Shechter Ravid
MyMilk Laboratories Ltd. Herzliya, Herzliya, Israel.
Department of Nutrition Sciences, Faculty of Health Sciences, Ariel University, Ariel, Israel.
BMC Pregnancy Childbirth. 2025 Jan 23;25(1):60. doi: 10.1186/s12884-025-07141-x.
Human milk electrolytes are known biomarkers of stages of lactation in the first weeks after birth. However, methods for measuring milk electrolytes are available only in laboratory or expert settings. A small handheld milk sensing device (Mylee) capable of determining on-site individual secretory activation progress from sensing the conductivity of a tiny milk specimen was developed. Here we evaluate the validity of a novel milk-sensing device (Mylee) for measuring the progress of milk maturation and secretory activation status.
Retrospective data analysis of laboratory records generated using the Mylee device. Device conductivity measurements were assessed for accuracy, reliability and stability in rigorous laboratory tests with standard materials. A set of human milk specimens (n = 167) was used to analyze the agreement between the milk maturation score and laboratory measurements of the secretory activation biomarker milk sodium [Na+].
The Mylee device was demonstrated to have excellent reproducibility (CV5%) and accuracy (error < 5%) for conductivity measurements of a small specimen (350 µl), with good device stability and almost perfect inter-device unit reliability (ICC > 0.90). With regression analysis, we revealed excellent agreement between Mylee milk maturation (MM%) output or its raw conductivity signal and laboratory measurements of conductivity and sodium [Na+] in a dataset of milk specimens (n = 167; R > 0.9). The Mylee MM% score showed good predictive ability for secretary activation status, as determined by sodium threshold (18 mmol/L) in human milk specimens.
In this study, we demonstrated the reliability and validity of the Mylee device and its ability to detect on-site milk secretory activation in a manner comparable to that of electrolyte-based methods. The novel MyLee device offers the potential to generate real-time information about the lactation stage, measured by mothers at the commodity of their home.
人乳电解质是出生后最初几周泌乳阶段的已知生物标志物。然而，测量乳电解质的方法仅在实验室或专业环境中可用。开发了一种小型手持式乳汁传感设备（Mylee），该设备能够通过检测微量乳汁样本的电导率来现场确定个体分泌激活进程。在此，我们评估一种新型乳汁传感设备（Mylee）用于测量乳汁成熟进程和分泌激活状态的有效性。
对使用Mylee设备生成的实验室记录进行回顾性数据分析。在使用标准材料的严格实验室测试中，评估设备电导率测量的准确性、可靠性和稳定性。使用一组人乳样本（n = 167）分析乳汁成熟评分与分泌激活生物标志物乳钠[Na+]的实验室测量值之间的一致性。
对于小样本（350微升）的电导率测量，Mylee设备表现出出色的重现性（CV<5%）和准确性（误差<5%），具有良好的设备稳定性和几乎完美的设备间单元可靠性（ICC>0.90）。通过回归分析，我们发现在乳汁样本数据集（n = 167；R>0.9）中，Mylee乳汁成熟度（MM%）输出或其原始电导率信号与电导率和钠[Na+]的实验室测量值之间具有出色的一致性。Mylee MM%评分对人乳样本中钠阈值（18 mmol/L）所确定的分泌激活状态具有良好的预测能力。
在本研究中，我们证明了Mylee设备的可靠性和有效性，以及它以与基于电解质的方法相当的方式现场检测乳汁分泌激活的能力。新型MyLee设备有可能生成关于泌乳阶段的实时信息，由母亲在家中自行测量。
