Đánh giá độ đồng nhất, kiểm tra chất lượng xét nghiệm vi sinh lâm sàng dạng bệnh phẩm giả định máu, phân, nước tiểu chứa vi khuẩn dược sản xuất ở quy mô Pilot

Vietnam Ministry of Health declared that external quality assessment scheme (EQAs) is the mandatory requirements in the regulation of quality management of medical laboratory, to expand the EQAs, we need the EQAs materials, especially in clinical microbiology, however, because of many objective reasons, there is no commercial companies (manufacturing in Vietnam or importing) supplying EQAs materials for external quality assessment of this diagnostic field. After the achievement of study in optimizing factors, conditions, ingredients, ... and apply to manufacturing process for assuming blood, stool, urine specimens, the authors manufactured these specimens in pilot, evaluate the homogeneity and stability of them. Results, three specimens with the bacteria: blood (Staphylococcus epidermidis, Acinetobacter baumannii, contaminated Burkholderia cepacia), stool (Shigella sonnei, Salmonella paratyphi A, contaminated Proteus vulgaris), urine (Proteus vulgaris, Enterococcus faecalis) from the process of the study in pilot were complied the standardization of homogeneity, they also were stable 15 days during the storage condition as 20°C, humidity 75 percent, suitable for EQAs materials.