Development and analytical validation of nanoparticle-enhanced immunochromatographic assay for rapid detection of...

Area of Science:

• Biotechnology
• Immunology
• Nanotechnology

Background:

• Hepatitis C virus (HCV) infection poses a significant global health challenge, particularly in resource-limited settings.
• Accessible and reliable diagnostic tools are crucial for effective HCV screening and management worldwide.

Purpose of the Study:

• To develop and analytically assess a novel immunochromatographic test (ICT) for detecting anti-HCV antibodies in human serum.
• To optimize the ICT assay using gold nanoparticles (AuNPs) for enhanced sensitivity, specificity, and signal intensity.

Main Methods:

• Gold nanoparticles (AuNPs) were synthesized via a redox method and optimized for antibody and antigen conjugation.
• Assay parameters including buffer formulation, surface functionalization, pH, protein concentration, and blocking conditions were meticulously optimized.
• The developed ICT assay was evaluated using clinical serum samples to determine diagnostic performance metrics.

Main Results:

• The optimized ICT assay demonstrated high diagnostic performance: 97.5% sensitivity, 98.2% specificity, and 97.6% accuracy.
• The assay achieved a low limit of detection (ELISA S/Co ≈ 1.14) with excellent linearity (R² = 0.991), suitable for detecting low-level antibodies.
• Rapid results were obtained within 10-15 minutes, with enhanced signal intensity compared to conventional lateral flow systems.

Conclusions:

• The developed gold nanoparticle-based ICT assay is a robust, scalable, and cost-effective platform for Hepatitis C virus screening.
• This novel diagnostic tool offers improved performance and speed, addressing the need for accessible HCV testing, especially in underserved regions.