Quality control on novel portable optical-based coagulation detector and reagent inventory

• Main Authors: Wei-TsuChang, 張維志
• Other Authors: Kung-Chia Young
• Format: Others
• Language: en_US
• Published: 2018
• Online Access: http://ndltd.ncl.edu.tw/handle/a5spkv

碩士 === 國立成功大學 === 醫學檢驗生物技術學系 === 106 === Quality management and efficiency has been considered as an important issue in laboratory diagnosis. As U.S. Food and Drug Administration (FDA) recommended, coagulation analyzer should avoid substance interference before becoming a product. In this study, the effects of potential interferents on a novel portable optical-based coagulation detector were examined, including hematocrit, hemoglobin, bilirubin, triglyceride, cation, antibiotic, heparin and polybrene. The coagulation trigger tissue factor was coated on the chips by lyophilization, which was reported to stress and disrupt the structure of the liposomes imposed during the process. By using cryo-electron microscopy (cryo-EM), the structure of liposome was clearly visualized. Besides lyophilization, heat tolerance of the reagent was also accessed by cryo-EM morphology and PT functional measurement. World Health Organization (WHO) quality management recommended that the supply and reagent inventory management system might facilitate the improvement of the efficiency and quality of diagnostic laboratories. Taking advantage of network and mobile devices, a new approach to manage the supply and reagent was established. The study results included that (1) the addition of interferents might not affect the PT measurement; (2) the structure of liposome remained intact after lyophilization; (3) The PT reagent remained active after heating at 90˚C for 30 minutes; (4) the rate of dissolving and the degree of mixing were the bottleneck for lyophilized-reagent chips to generate a detectable PT signal; (5) an application for real-time inventory management was invented, with the application allowing managers to monitor the inventory real-timely in more convenience and efficient way.