Comparative Analysis of RT-PCR and a Colloidal Gold Immunochromatographic Assay for SARS-CoV-2 Detection

Area of Science:

• Infectious Disease Diagnostics
• Biotechnology
• Public Health

Background:

• The COVID-19 pandemic necessitates rapid, accurate, and accessible SARS-CoV-2 diagnostics.
• Reverse transcription-polymerase chain reaction (RT-PCR) is the gold standard but has limitations in speed and accessibility.
• Colloidal gold immunochromatographic assay (GICA) presents a potential alternative for large-scale and point-of-care testing.

Purpose of the Study:

• To systematically evaluate the diagnostic performance of GICA compared to RT-PCR for SARS-CoV-2 detection.
• To assess GICA's effectiveness as a complementary or alternative tool, especially in resource-limited settings.
• To investigate the correlation between GICA signal intensity and RT-PCR cycle threshold (Ct) values.

Main Methods:

• Comparative analysis of RT-PCR and GICA diagnostic performance.
• Assessment of key clinical parameters: sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and accuracy.
• Regression analysis and receiver operating characteristic (ROC) curve analysis to correlate GICA signal with RT-PCR Ct values.

Main Results:

• GICA demonstrated a strong correlation with RT-PCR results, offering a rapid alternative.
• While RT-PCR showed higher sensitivity, GICA provided results within 20 minutes, unlike RT-PCR's extended processing times.
• GICA is a cost-effective option suitable for decentralized testing and real-time public health interventions.

Conclusions:

• GICA can serve as a valuable complementary diagnostic tool alongside RT-PCR, particularly in resource-limited and high-throughput screening scenarios.
• Integrating GICAs enhances early detection, improves diagnostic accessibility, and strengthens pandemic response capabilities.
• GICA offers a viable solution for rapid, large-scale SARS-CoV-2 screening and public health management.