Ko Cheng-Hao, Kong Wei-Yi, Kabiso Abel Chernet, Chiu Wei-Huai, Tadesse Ashenafi Belihu, Hong Chitsung, Wu Chia-Fang, Lin Hung-Hsun
Graduate Institute of Automation and Control, National Taiwan University of Science and Technology, Taipei 106, Taiwan.
SpectroChip Inc., Hsinchu 310, Taiwan.
Toxics. 2024 Nov 29;12(12):870. doi: 10.3390/toxics12120870.
Growing concerns about the health risks of melamine adulteration in food products highlight the urgent need for reliable detection methods. However, the long-term effects of chronic low-level melamine exposure remain inadequately explored. This study introduces THE ONE InstantCare platform, a portable immunoassay analyzer integrating a SpectroChip-based spectral processing unit (SPU) with lateral flow immunoassay (LFIA) for sensitive and accurate quantification of melamine in human urine. This platform provides a cost-effective, rapid, and user-friendly point-of-care (POC) solution for melamine detection. Analytical evaluations across eight melamine concentrations (0-100 parts per billion, ppb) achieved a limit of detection (LOD) of 1.91 ppb. Validation with 24 human urine samples demonstrated strong concordance with liquid chromatography-mass spectrometry (LC-MS), yielding an intraclass correlation coefficient (ICC) of 0.9220, a Pearson correlation coefficient of 0.9389, and 95% agreement in Bland-Altman analysis. High reproducibility was observed, with an intraday coefficient of variation (CV) of 6.53% and acceptable interday CV values, while interference studies confirmed reliability in the presence of common biological substances. By delivering results in approximately 10 min, THE ONE InstantCare platform significantly reduces analysis time compared to LC-MS, which typically requires several hours. This novel platform enhances food safety surveillance and advances human health risk assessments, particularly for evaluating melamine-linked kidney damage. Its versatility and robust performance make it a promising tool for environmental monitoring and clinical diagnostics, enabling the detection of diverse biomarkers with high sensitivity and reproducibility.
对食品中三聚氰胺掺假健康风险的日益担忧凸显了对可靠检测方法的迫切需求。然而，长期低水平三聚氰胺暴露的长期影响仍未得到充分探索。本研究介绍了THE ONE即时护理平台，这是一种便携式免疫分析分析仪，将基于光谱芯片的光谱处理单元（SPU）与侧向流动免疫分析（LFIA）相结合，用于灵敏、准确地定量测定人尿中的三聚氰胺。该平台为三聚氰胺检测提供了一种经济高效、快速且用户友好的即时检测（POC）解决方案。对八种三聚氰胺浓度（0 - 100十亿分之一，ppb）进行的分析评估实现了1.91 ppb的检测限（LOD）。对24份人类尿液样本的验证表明与液相色谱 - 质谱联用（LC - MS）具有高度一致性，组内相关系数（ICC）为0.9220，皮尔逊相关系数为(0.9389)，在布兰德 - 奥特曼分析中一致性为(95%)。观察到高重现性，日内变异系数（CV）为(6.53%)，日间CV值可接受，同时干扰研究证实了在常见生物物质存在下的可靠性。通过在大约10分钟内给出结果，THE ONE即时护理平台与通常需要数小时的LC - MS相比，显著缩短了分析时间。这个新颖的平台加强了食品安全监测并推进了人类健康风险评估，特别是对于评估与三聚氰胺相关的肾脏损伤。其多功能性和强大性能使其成为环境监测和临床诊断的有前途的工具，能够以高灵敏度和重现性检测多种生物标志物。
