Sản xuất thử nghiệm mẫu ngoại kiểm nước tiểu định lượng dạng lỏng cho xét nghiệm albumin niệu và protein niệu

Abstract

In Vietnam, external quality assessment (EQA) materials for urine quantitative tests mostly come from imported products, which are costly and not aligned with actual practices that primarily focus on urine albumin and protein. This laboratory-based experimental study focused on the development of liquid-based EQA materials for urine albumin and protein quantitation, with quality assessment performed in accordance with ISO 13528:2022. Three batches of EQA materials were produced with urine albumin concentrations of 43; 180; and 387 mg/L, and urine protein concentrations of 0.08; 0.22; and 0.42 g/L, respectively, covering all medical decision levels. All batches met requirements for homogeneity, transport stability, and long-term stability for up to 8 weeks at 2 - 8°C. This study demonstrates the feasibility of domestic production of urine chemistry EQA materials that meet international standards and have strong potential for practical implementation.