NGHIÊN CỨU MẪU SINH PHẨM HUYẾT HỌC TRONG KIỂM TRA CHẤT LƯỢNG XÉT NGHIỆM HUYẾT HỌC NỒNG ĐỘ CAO

Abstract

Hematological reference samples for external quality assessment (EQA) in hematology are essential in Vietnam. This study attempted to establish an optimal formula for manufacture of hematological reference samples with high concentration. Three main factors affecting the concentrations of RBCs (/L) determined using Plackett-Burmann matrix were the serum (% v/v), neomycin sulfate (g/L), and glycerol (%v/v) with a significance level of 0.1. The optimal concentrations determined by RSM-CCD were 46.46% serum, 0.82 g/L neomycin sulfate, and 1.22% glycerol. The model predicted the maximum number of human RBCs was 5.1 x 10¹² cells/L, pseudo-leucocytes was 16.2 x 10⁹ cells/L, and pseudo-platelets was 449 x10⁹ cells/L. The practical concentrations of RBCs, pseudo-leucocytes and pseudo-platelets were 5.06 x 10¹² cells/L, 16.0 x 10⁹ cells/L and 450.33 x 10⁹ cells/L, respectively, which showed 99.23 % similarity with theoretical data; homogeneity and stability under laboratory conditions for 3 months at 2-8°C and transport conditions. This result could be a premise for further study to improve manufacturing of hematological reference samples for hematology EQA programs.