Portable SpectroChip-Based Immunoassay Platform for Rapid and Accurate Melamine Quantification in Urine Samples.

Abstract

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.