Development of plasma material preparation for Rapid HIV Antibody Test

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