KHẢO SÁT ĐẶC ĐIỂM BỘ MẪU HUYẾT THANH ĐÔNG KHÔ CHỨA THÔNG SỐ K+ VÀ CA++ ỨNG DỤNG CHO CHƯƠNG TRÌNH NGOẠI KIỂM HÓA SINH

Abstract

Objective: The study aims to investigate the homogeneity and stability of the lyophilized serum samples containing potassium and calcium ions parameters used in external quality assessment. Research method: Experimental research was conducted on lyophilized serum samples used in external quality assessment containing potassium and calcium parameters. The homogeneity of the samples was evaluated, and the concentration of the parameters among the samples was ensured to be homogeneity with s_s ≤ 0,3ϭ_pt. The stability over time and under different storage conditions of the sample sets after production was assessed. The sample sets were considered stable at the evaluation time when |y̅_i – y̅₁| ≤ 0,3ϭ_pt. Results: Successful production was achieved for 2 dried serum sample sets containing potassium and calcium parameters. Batch A had concentrations within normal limits of 3.25 mmol/L for potassium and 1.25 mmol/L for calcium, while Batch B had higher concentrations of 5.85 mmol/L for potassium and 1.42 mmol/L for calcium. Both batches of external quality control samples ensured homogeneity of concentration among samples and stability in the laboratory environment for up to 24 hours at temperatures ranging from 20°C to 28°C. Additionally, both batches remained stable during storage for up to 1 month at temperatures of 2°C to 8°C, -20°C, and -80°C. Conclusion: The study successfully added potassium and calcium parameters to the electrolytes in external quality assessment sample sets at two concentration levels with homogeneity and stability, meeting the criteria of ISO 13528:2022 standards and suitable for implementation in external quality assessment in Vietnam.