http://nuir.lib.nu.ac.th/dspace/handle/123456789/4474 Faculty of Medical Science 2026-04-07T10:08:07Z http://nuir.lib.nu.ac.th/dspace/handle/123456789/6966 Title: Development of Plasma Material Preparation for Rapid Anti-hepatitis C test Authors: Wipawee Thanyacharern Abstract: Quality control samples play a vital role in ensuring the validity of laboratory results during quality control analysis. This study assessed the effectiveness of different quality control sample preparations for hepatitis C testing. The samples included liquid forms with and without stabilizers, as well as lyophilized samples with and without trehalose. The objective was to develop and optimize plasma materials for use with hepatitis C rapid diagnostic test (RDT) kits by evaluating preparation methods, creating a linearity panel for analytical validation, and examining the homogeneity and stability of the plasma materials. The analysis demonstrated that the prepared plasma materials were commutable and could be effectively utilized across all five rapid test kits. The concentrations of these materials were suitable for monitoring quality control in testing, and the plasma materials exhibited consistent performance. Stability studies indicated that the plasma materials remained stable for up to six months when stored at temperatures of 2-8°C and 25 ± 5°C, and for up to 28 days at 37°C and 45°C. In conclusion, the plasma materials developed for hepatitis C antibody testing were prepared using lyophilization with trehalose. Three levels of quality control samples were created: strong positive, weak positive, and negative. Furthermore, the linearity panel materials for Elecsys Anti-HCV II were prepared at six different concentrations to validate and ensure the accuracy of analytical systems in HCV diagnostics. The prepared plasma materials demonstrated homogeneity and stability, maintaining consistency for up to six months at temperatures between 2-8°C and 25 ± 5°C, and for up to 28 days at 37°C and 45°C Description: M.S. Thesis in Biomedical Sciences - (Type A 1) 2025-01-01T00:00:00Z http://nuir.lib.nu.ac.th/dspace/handle/123456789/6965 Title: Development of plasma material preparation for Rapid HIV Antibody Test Authors: Siriphailin Jomjumyoung Abstract: In Thailand, HIV rapid diagnostic tests ( HIV RDTs) are widely utilized in clinical laboratories and are essential for accurate diagnostics. Laboratory test data provide critical information necessary for reliable HIV diagnoses. While quality control (QC) samples are essential to ensure consistent test performance, they are not included in the rapid HIV test kits. This study focused on validating HIV-positive plasma materials as commutable, homogeneous, and stable internal quality control materials for clinical laboratories. Plasma materials were prepared for five different rapid HIV antibody test kits using two methods: lyophilization (freeze-drying) and liquid preparation. Each method was evaluated both with and without the inclusion of a stabilizing agent. The results demonstrated the successful development of HIV strong-positive plasma materials that exhibited compatibility with all five rapid HIV antibody test kits. However, HIV weak-positive plasma materials showed compatibility with only four kits. The study found that lyophilization combined with trehalose as a stabilizing agent emerged as the most effective protocol for achieving high stability in QC sample preparation. Moreover, the study determined the optimal preparation method to ensure both stability and homogeneity of the plasma materials, thereby establishing a dependable process for their development. Conclusively, lyophilization with trehalose was confirmed as the most effective approach for producing stable QC samples. The HIV strong-positive plasma materials were compatible with all five rapid HIV test kits, while the HIV weak-positiveplasma CD materials were compatible with four kits. The prepared plasma materials were stable and deemed suitable for use as quality control samples and linearity panels in HIV testing Description: M.S.Thesis in Biomedical Sciences - (Type A1) 2025-01-01T00:00:00Z http://nuir.lib.nu.ac.th/dspace/handle/123456789/6921 Title: ความไวในการตรวจจับข้อผิดพลาดของอุปกรณ์รับภาพอิเล็กทรอนิกส์สำหรับการประกันคุณภาพแผนการักษามะเร็งศีรษะและลำคอ ด้วยเทคนิคการฉายรังสีแบบปรับความเข้มเชิงปริมาตร Authors: ชัญชกร ไทยวัฒนา Description: วิทยานิพนธ์ วท.ม. ฟิสิกส์การแพทย์ 2568-01-01T00:00:00Z http://nuir.lib.nu.ac.th/dspace/handle/123456789/6900 Title: The study of properties and factors affecting the commutability of pooled blood material for HbA1C measurements Authors: Kanokwan Ngueanchanthong Abstract: Measurement of hemoglobin A1 C (HbA1 C) is essential for the diagnosis and treatment of diabetes mellitus (DM). Processed blood materials (PBMs), such as frozen pooled blood (FPB), are commonly used for External Quality Assessment (EQA). However, their commutability may be affected by factors such as hemolysis and matrix modification. This study evaluated the commutability of FPB and identified the factors influencing their performance in HbA1C measurements. HbA1C contents in 24 clinical blood samples (CBSs) and 10 PBMs, including FPBs, singledonor blood (SDB), and in vitro glycated blood (IGB), were analyzed using enzymatic (EN), capillary electrophoresis (CE), cation-exchange high-performance liquid chromatography (CE-HPLC), turbidimetric immunoassay (TI), and boronate affinity HPLC (BA-HPLC). EN served as the reference measurement procedure. Commutability was assessed using Deming regression and 95 prediction intervals. The hematocrit (HCT), visual appearance, plasma absorbance (PA), hemolysis index (HI), pH, and debris cells (DC) were analyzed. FPB1 and SDB were commutable across all measurement procedures. FPB2 and FPB4 were commutable with CE, CE-HPLC, and TI but non-commutable with BA-HPLC when HbA1C was ≥6.23%, as data points fell outside the tolerance limits of the Deming regression lines. Non-commutable PBMs showed higher PA and HI along with lower pH. DC affected HbA1 C quantificationC using CE-HPLC. Hemolysis, as assessed by PA and HI, affects FPB commutability. These factors should be considered in EQA programs, particularly for BA-HPLC. HCT and DC did not directly affect commutability; however, maintaining appropriate HCT levels and monitoring DC-related chromatographic interference are crucial for ensuring FPB reliability in HbA1C comparisons Description: Thesis Ph.D. Biomedical Sciences - (Type A 1) 2025-01-01T00:00:00Z