Genetically engineered pair of cells for serological testing and its application for SARS-CoV-2

Area of Science:

• Immunology
• Cell Biology
• Diagnostic Development

Background:

• Accurate serology tests are crucial for tracking viral infections and managing public health risks.
• Existing methods may require complex procedures or lack rapid results.

Purpose of the Study:

• To develop and validate a novel, rapid, and cost-effective cell-based serology test platform.
• To assess the platform's performance in detecting antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Main Methods:

• Engineered a pair of cell lines into a Diagnostic-Cell-Complex (DxCell-Complex).
• The complex utilizes immune synapse formation for dual-reporter protein expression upon antibody detection.
• Validated with human serum samples from individuals with confirmed SARS-CoV-2 infection.

Main Results:

• The DxCell-Complex quantitatively detected SARS-CoV-2 specific immunoglobulin G (IgG) within 1 hour.
• Achieved 97.04% sensitivity and 93.33% specificity in clinical human serum validation.
• Demonstrated no need for signal amplification steps, simplifying the assay.

Conclusions:

• The DxCell-Complex platform provides a rapid, sensitive, and specific method for viral infection serology.
• The platform's design allows for adaptation to detect other antibodies, offering broad diagnostic potential.
• Cellular attributes enable cost-effective manufacturing and operation in diverse healthcare settings.