Related Experiment Video
Updated: Jun 28, 2026
Rapid Screening of HIV Reverse Transcriptase and Integrase Inhibitors
Published on: April 9, 2014
Development and Evaluation of a Lyophilized Plasma-Based Internal Quality Control for Human Immunodeficiency Virus
Siriphailin Jomjunyoung1,2, Wanvisa Treebuphachatsakul1,3, Supaporn Suparak2
1Reference Materials and Innovation Research Unit for Medical Laboratory, Faculty of Allied Health Sciences, Naresuan University, Phitsanulok 65000, Thailand.
Insights
New internal quality control (IQC) materials for human immunodeficiency virus (HIV) rapid diagnostic tests (RDTs) were developed. Trehalose-stabilized lyophilized plasma showed long-term stability, compatible with multiple HIV RDT brands without cold-chain needs.
Area of Science:
- Clinical diagnostics
- Biotechnology
- Immunology
Background:
- Rapid diagnostic tests (RDTs) for human immunodeficiency virus (HIV) are crucial for widespread screening.
- Most commercially available HIV RDT kits lack standardized internal quality control (IQC) materials.
- The absence of reliable IQC hinders accurate and consistent test performance.
Purpose of the Study:
- To develop and evaluate a stable, plasma-based IQC material for HIV RDTs.
- To ensure compatibility of the developed IQC with multiple leading HIV RDT brands.
- To assess the long-term stability of the IQC material under various storage conditions.
Main Methods:
- Three reactivity levels of plasma control samples were prepared in lyophilized and liquid forms.
- Lyophilized samples were formulated with or without trehalose; liquid samples with or without a stabilizer.
- Accelerated stability testing at 37°C and 45°C for 28 days, followed by long-term storage assessment at 4°C and 25°C.
- Stability was determined by analyzing test-line visibility and signal intensity using linear regression (p > 0.05 for stability).
Main Results:
- Trehalose-containing lyophilized plasma samples demonstrated consistent reactivity and signal intensity.
- These samples maintained stability during accelerated testing (37°C, 45°C) and for 6 months at 4°C and 25°C.
- No significant changes in signal intensity were observed (p > 0.05), indicating high stability.
Conclusions:
- Developed plasma-based IQC materials are compatible with five major HIV RDT brands.
- Trehalose-stabilized lyophilized plasma exhibits excellent long-term stability.
- This IQC formulation supports simplified transport and storage, potentially without requiring a strict cold chain.
Abstract:
Background/Objectives: Rapid diagnostic tests (RDTs) for human immunodeficiency virus (HIV) are widely used, but most kits lack standardized internal quality control (IQC) materials. In this study, we aimed to develop and evaluate a plasma-based IQC compatible with five HIV RDT brands and with proven long-term stability. Methods: Control samples at three reactivity levels were tested with five HIV RDT kits in lyophilized and liquid forms. Lyophilized samples were produced with and without trehalose, whereas liquid samples were prepared with and without StabilZyme™ SELECT Stabilizer (Stabilizer). Accelerated stability testing was performed at 37 °C and 45 °C for 28 days, and the most stable formulation was selected for long-term storage at 4 ± 2 °C and 25 ± 5 °C. Stability was assessed based on test-line visibility and signal intensity. Signal-intensity trends were analyzed using simple linear regression with a t-test on the slope; samples were considered stable when no significant trend was detected (p > 0.05). Results: Reactivity measured using the Elecsys HIV combi PT assay yielded cutoff index (COI) values of 772.65 (1:8) for the strong-positive control and 269.95 (1:25) for the weak-positive control. Trehalose-containing lyophilized samples maintained reactivity under accelerated testing at 37 and 45 °C and for 6 months at 4 ± 2 °C and 25 ± 5 °C, with no significant change in signal intensity (p > 0.05). Conclusions: The plasma-based IQC materials were compatible with all five HIV RDTs, and trehalose-stabilized lyophilized plasma showed high stability, supporting transport and storage without strict cold-chain requirements.
