Halo-A Universal Fluorescence Reader Based Threat Agent Detection Platform-A Proof of Concept Study Using SARS-CoV-2...

Area of Science:

• Medical Diagnostics
• Infectious Disease Detection
• Point-of-Care Testing

Background:

• Polymerase chain reaction (PCR) is highly sensitive but costly and complex.
• Rapid antigen tests are accessible but lack sensitivity compared to PCR.
• There is a critical need for sensitive, rapid, and accessible diagnostic solutions.

Purpose of the Study:

• To develop a low-cost diagnostic platform for rapid SARS-CoV-2 detection.
• To compare the analytical performance of the Halo™ platform against existing rapid test technologies.
• To evaluate the platform's sensitivity and variant inclusivity in simulated nasal matrices.

Main Methods:

• Development of a diagnostic platform (Halo™) with fluorescently labeled lateral flow assays.
• Comparison of Halo™ against colloidal gold nanoparticle and fluorescence-based reporters.
• Analytical testing in simulated nasal matrix using live SARS-CoV-2 virus variants.

Main Results:

• The Halo™ platform demonstrated a limit of detection of 1.9 TCID50/test for the SARS-CoV-2 delta variant in a simulated nasal matrix.
• The system showed comparable sensitivity across all tested SARS-CoV-2 variants.
• Assay performance was not negatively impacted by mutations in the tested SARS-CoV-2 variants.

Conclusions:

• The Halo™ platform offers a promising solution for sensitive, rapid, and accessible SARS-CoV-2 detection.
• The technology may enable feasible single-assay detection of asymptomatic infections.
• The platform's consistent performance across variants suggests broad applicability for future SARS-CoV-2 monitoring.