Fully Automated Chemiluminescence Microarray Analysis Platform for Rapid and Multiplexed SARS-CoV-2 Serodiagnostics.

Area of Science:

• Biomedical Engineering
• Immunology
• Analytical Chemistry

Background:

• Lateral-flow immunoassays (LFIAs) and enzyme-linked immunosorbent assays (ELISAs) are key COVID-19 diagnostics.
• Existing methods have limitations: LFIAs lack sensitivity/specificity, while lab tests are slow and labor-intensive.
• There is a need for rapid, sensitive, specific, and multiplexed diagnostic systems for point-of-care (POC) use.

Purpose of the Study:

• To develop a novel bioanalytical system combining the advantages of LFIAs and laboratory immunoassays.
• To create a multiplexed assay for simultaneous detection of multiple immunorecognition patterns.
• To validate the system for rapid and reliable detection of SARS-CoV-2 antibodies.

Main Methods:

• Development of laminated polycarbonate microarray chips for easy production.
• Utilized a fully automated microarray analysis platform (MCR-R) with a novel flow cell design.
• Minimized sample volume to 40 μL for efficient analysis.
• Employed recombinant antigens for SARS-CoV-2 spike S1 protein, nucleocapsid protein, and receptor binding domain.

Main Results:

• Achieved 100% sensitivity and specificity in detecting IgG antibodies to SARS-CoV-2.
• Completed analysis within 4 minutes using serum, plasma, and whole blood.
• Demonstrated multiplexing capability and sequential detection of IgM and IgG antibodies.
• Showcased potential for serosurveillance and monitoring antibody decline for booster vaccination needs.

Conclusions:

• The developed flow-based chemiluminescence microarray immunoassay is a powerful, rapid, and reliable diagnostic tool.
• The system is suitable for point-of-care (POC) settings and serosurveillance applications.
• The adaptable platform holds promise for future serological testing for various diseases.