Development of Plasma Material Preparation for Rapid Anti-hepatitis C test

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